id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id
FDA-2000-N-0158-0066,FDA,FDA-2000-N-0158,"Reference 1, Orthopaedic and Rehabilitation Devices Panel - FDA Executive Summary re Physical Medicine Devices; Reclassification of Iontophoresis Device Intended for Any Other Purposes",Supporting & Related Material,Background Material,2016-08-05T04:00:00Z,2016,8,,,2016-08-05T16:18:02Z,,0,0,0900006482158cf1
FDA-2000-N-0158-0065,FDA,FDA-2000-N-0158,List of References for Final Order- Reclassification of Iontophoresis Devices Intended for Any Other Purposes re Physical Medicine Devices; Reclassification of Iontophoresis Device Intended for Any Other Purposes,Supporting & Related Material,Background Material,2016-08-05T04:00:00Z,2016,8,,,2016-08-05T16:16:44Z,,0,0,0900006482158c8e
FDA-2000-N-0158-0067,FDA,FDA-2000-N-0158,Reference 1a. Orthopaedic and Rehabilitation Devices Panel - 2014 Meeting Materials re Physical Medicine Devices; Reclassification of Iontophoresis Device Intended for Any Other Purposes,Supporting & Related Material,Background Material,2016-08-05T04:00:00Z,2016,8,,,2016-08-05T16:19:38Z,,0,0,0900006482158cf2
FDA-2000-N-0158-0064,FDA,FDA-2000-N-0158,Physical Medicine Devices; Reclassification of Iontophoresis Device Intended for Any Other Purposes,Rule,Final Rule,2016-07-26T04:00:00Z,2016,7,2016-07-26T04:00:00Z,,2016-07-26T14:37:46Z,2016-17609,0,0,09000064821222d9
FDA-2000-N-0158-0057,FDA,FDA-2000-N-0158,"Reclassification of Iontophoresis Devices Intended for Any Other
Purposes",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2014-09-22T04:00:00Z,2014,9,2014-09-22T04:00:00Z,2014-12-23T04:59:59Z,2014-12-23T03:01:11Z,2014-22453,0,0,0900006481885b66
FDA-2000-N-0158-0058,FDA,FDA-2000-N-0158,List of References reReclassification of Iontophoresis Devices Intended for Any Other Purposes,Supporting & Related Material,Background Material,2014-09-22T04:00:00Z,2014,9,,,2014-09-30T16:44:35Z,,0,0,090000648188626d
FDA-2000-N-0158-0060,FDA,FDA-2000-N-0158,"Reference 1-A  - Meeting Materials for the February 21, 2014, meeting of the Orthopaedic and Rehabilitation Devices Panel re Reclassification of Iontophoresis Devices Intended for Any Other Purposes",Supporting & Related Material,Background Material,2014-09-22T04:00:00Z,2014,9,,,2014-09-30T16:44:51Z,,0,0,090000648188626e
FDA-2000-N-0158-0059,FDA,FDA-2000-N-0158,"Reference 1 - Meeting Materials for the February 21, 2014, meeting of the Orthopaedic and Rehabilitation Devices Panel re Reclassification of Iontophoresis Devices Intended for Any Other Purposes",Supporting & Related Material,Background Material,2014-09-22T04:00:00Z,2014,9,,,2014-09-30T16:44:43Z,,0,0,090000648188626f
FDA-2000-N-0158-0055,FDA,FDA-2000-N-0158,"Attachment 3  re Comment from IOMED Inc., FDA-2000-N-0158-0009",Supporting & Related Material,Background Material,2014-09-15T04:00:00Z,2014,9,,,2014-09-15T15:51:17Z,,0,0,09000064804d1791
FDA-2000-N-0158-0049,FDA,FDA-2000-N-0158,Attachment 14   Didronel  re Comment from Empi Inc FDA-2000-N-0158-0035,Supporting & Related Material,Background Material,2014-09-10T04:00:00Z,2014,9,,,2014-09-10T15:14:46Z,,0,0,09000064804d177f
FDA-2000-N-0158-0046,FDA,FDA-2000-N-0158,Attachment 11   Predcription Drug Product List re Comment from Empi Inc FDA-2000-N-0158-0035,Supporting & Related Material,Background Material,2014-09-10T04:00:00Z,2014,9,,,2014-09-10T14:57:08Z,,0,0,09000064804d1784
FDA-2000-N-0158-0053,FDA,FDA-2000-N-0158,"Attachment 2  Comments - Propsed Rule Federal Refigister 69:64313 November 4, 2004  re Comment from IOMED Inc., FDA-2000-N-0158-0009",Supporting & Related Material,Background Material,2014-09-10T04:00:00Z,2014,9,,,2014-09-10T20:55:33Z,,0,0,09000064804d1790
FDA-2000-N-0158-0047,FDA,FDA-2000-N-0158,Attachment 12   Betoptic S Ophthalmic Suspension 0.25 Percent re Comment from Empi Inc FDA-2000-N-0158-0035,Supporting & Related Material,Background Material,2014-09-10T04:00:00Z,2014,9,,,2014-09-10T15:05:30Z,,0,0,09000064804d177b
FDA-2000-N-0158-0052,FDA,FDA-2000-N-0158,"Attachment 1  Cover letter re Comment from IOMED Inc., FDA-2000-N-0158-0009",Supporting & Related Material,Background Material,2014-09-10T04:00:00Z,2014,9,,,2014-09-10T20:48:15Z,,0,0,09000064804d178e
FDA-2000-N-0158-0044,FDA,FDA-2000-N-0158,Attachment 8  Treatment of Fungus Infections of the Extremities by the Iontophoresis of Copper Fistula Electrode Current  re Comment from Empi Inc FDA-2000-N-0158-0035,Supporting & Related Material,Background Material,2014-09-10T04:00:00Z,2014,9,,,2014-09-10T14:43:03Z,,0,0,09000064804d1777
FDA-2000-N-0158-0045,FDA,FDA-2000-N-0158,Attachment 10   Affidavit of Donald Maurer re Comment from Empi Inc FDA-2000-N-0158-0035,Supporting & Related Material,Background Material,2014-09-10T04:00:00Z,2014,9,,,2014-09-10T14:50:44Z,,0,0,09000064804d177a
FDA-2000-N-0158-0048,FDA,FDA-2000-N-0158,Attachment 13   Pharmaceutical Product Information Betoptic  Percent re Comment from Empi Inc FDA-2000-N-0158-0035,Supporting & Related Material,Background Material,2014-09-10T04:00:00Z,2014,9,,,2014-09-10T15:09:57Z,,0,0,09000064804d177d
FDA-2000-N-0158-0050,FDA,FDA-2000-N-0158,Attachment 15  Patanol re Comment from Empi Inc FDA-2000-N-0158-0035,Supporting & Related Material,Background Material,2014-09-10T04:00:00Z,2014,9,,,2014-09-10T16:34:49Z,,0,0,09000064804d1780
FDA-2000-N-0158-0032,FDA,FDA-2000-N-0158,"Attachment 21 J.Kahn, '' Acetic Acid Iontophoresis for Calcium Deposits, '' Physical Therapy 57/6: 658 June 1977  re Comment from Birch Point Medical Inc FDA 2000-N-0158-0011",Supporting & Related Material,Background Material,2014-09-09T04:00:00Z,2014,9,,,2014-09-09T14:43:50Z,,0,0,09000064804d1751
FDA-2000-N-0158-0043,FDA,FDA-2000-N-0158,Attachment 9   Advertisements re Comment from Empi Inc FDA-2000-N-0158-0035,Supporting & Related Material,Background Material,2014-09-09T04:00:00Z,2014,9,,,2014-09-09T21:00:25Z,,0,0,09000064804d1778
FDA-2000-N-0158-0037,FDA,FDA-2000-N-0158,Attachment 2 Civil Action No. 83-3314 STIPULATION AND ORDER OF DISMISSAL re Comment from Empi Inc FDA-2000-N-0158-0035,Supporting & Related Material,Background Material,2014-09-09T04:00:00Z,2014,9,,,2014-09-09T17:13:19Z,,0,0,09000064804d1768
FDA-2000-N-0158-0033,FDA,FDA-2000-N-0158,"Attachment 22  M-D-D-I Reports November 13, 1978 , at 2 re Comment from Birch Point Medical Inc FDA 2000-N-0158-0011",Supporting & Related Material,Background Material,2014-09-09T04:00:00Z,2014,9,,,2014-09-09T15:03:01Z,,0,0,09000064804d1753
FDA-2000-N-0158-0041,FDA,FDA-2000-N-0158,Attachment 6  APPENDIX TO PLAINTIFF'S MOTION FOR SUMMARY JUDGMENT  re Comment from Empi Inc FDA-2000-N-0158-0035,Supporting & Related Material,Background Material,2014-09-09T04:00:00Z,2014,9,,,2014-09-09T20:08:51Z,,0,0,09000064804d1773
FDA-2000-N-0158-0042,FDA,FDA-2000-N-0158,Attachment 7  Fistula Electrode - '' For Treatment of Fisculae with Positive Galvanic Current  re Comment from Empi Inc FDA-2000-N-0158-0035,Supporting & Related Material,Background Material,2014-09-09T04:00:00Z,2014,9,,,2014-09-09T20:16:59Z,,0,0,09000064804d1775
FDA-2000-N-0158-0040,FDA,FDA-2000-N-0158,Attachment 5  Use of Low-Voltage Electrotherapy and Electromygraphy in Physical Thearapy re Comment from Empi Inc FDA-2000-N-0158-0035,Supporting & Related Material,Background Material,2014-09-09T04:00:00Z,2014,9,,,2014-09-09T20:02:44Z,,0,0,09000064804d1770
FDA-2000-N-0158-0038,FDA,FDA-2000-N-0158,"Attachment 3 Civil Action No. 83-3314  November 19 , 1984 STIPULATION AND ORDER OF DISMISSAL re Comment from Empi Inc FDA-2000-N-0158-0035",Supporting & Related Material,Background Material,2014-09-09T04:00:00Z,2014,9,,,2014-09-09T19:48:28Z,,0,0,09000064804d1766
FDA-2000-N-0158-0039,FDA,FDA-2000-N-0158,Attachment 4 Affidavit Ervin Larrie Rhodes  re Comment from Empi Inc FDA-2000-N-0158-0035,Supporting & Related Material,Background Material,2014-09-09T04:00:00Z,2014,9,,,2014-09-09T19:56:25Z,,0,0,09000064804d176e
FDA-2000-N-0158-0034,FDA,FDA-2000-N-0158,"Attachment 23 Iomed 10-K June 30,2000 excerpts re Comment from Birch Point Medical Inc FDA 2000 N 0158 0011",Supporting & Related Material,Background Material,2014-09-09T04:00:00Z,2014,9,,,2014-09-09T15:03:22Z,,0,0,09000064804d1754
FDA-2000-N-0158-0031,FDA,FDA-2000-N-0158,"Attachment 19  V.Payne. '' My Results with Ionization Treatment in Nasal Allergy, '' Archives of Physical Therapy, X-Ray, Radium 18: 598 September 1937 re Comment from Birch Point Medical Inc FDA 2000-N-0158-0011",Supporting & Related Material,Background Material,2014-09-09T04:00:00Z,2014,9,,,2014-09-09T14:43:39Z,,0,0,09000064804d174e
FDA-2000-N-0158-0030,FDA,FDA-2000-N-0158,Attachment 16 Advertisement  DALLONS 1400MG 1964 re Comment from Birch Point Medical Inc FDA 2000-N-0158-0011,Supporting & Related Material,Background Material,2014-09-09T04:00:00Z,2014,9,,,2014-09-09T14:43:24Z,,0,0,09000064804d1749
FDA-2000-N-0158-0036,FDA,FDA-2000-N-0158,Attachment 1 Iontophoresis re Comment from Empi Inc FDA-2000-N-0158-0035,Supporting & Related Material,Background Material,2014-09-09T04:00:00Z,2014,9,,,2014-09-09T16:27:23Z,,0,0,09000064804d176a
FDA-2000-N-0158-0026,FDA,FDA-2000-N-0158,Attachment 15 Advertisement TECA SP-5 1963 re Comment from Birch Point Medical Inc FDA 2000-N-0158-0011,Supporting & Related Material,Background Material,2014-09-08T04:00:00Z,2014,9,,,2014-09-08T19:52:53Z,,0,0,09000064804d1748
FDA-2000-N-0158-0029,FDA,FDA-2000-N-0158,"Attachment 20 K. Harpuder, ''Electrophoretic Therapy: Problems and Value, '' N.Y. State Jour of Medicine 38/3: 176 February 1938 re Comment from Birch Point Medical Inc FDA 2000-N-0158-0011",Supporting & Related Material,Background Material,2014-09-08T04:00:00Z,2014,9,,,2014-09-08T20:40:50Z,,0,0,09000064804d174f
FDA-2000-N-0158-0025,FDA,FDA-2000-N-0158,Attachment 14 Advertisement MARK V 1963 re Comment from Birch Point Medical Inc FDA 2000-N-0158-0011,Supporting & Related Material,Background Material,2014-09-08T04:00:00Z,2014,9,,,2014-09-08T19:42:24Z,,0,0,09000064804d1746
FDA-2000-N-0158-0027,FDA,FDA-2000-N-0158,Attachment 17 Advertisement TECA SP-2 1964 re Comment from Birch Point Medical Inc FDA 2000-N-0158-0011,Supporting & Related Material,Background Material,2014-09-08T04:00:00Z,2014,9,,,2014-09-08T20:08:45Z,,0,0,09000064804d174b
FDA-2000-N-0158-0028,FDA,FDA-2000-N-0158,"Attachment 18 Abramson et al. , '' Skin Reactions. I. Mechanism of Histamine Iontophoresis from Aqueous Media, '' Archives of Physical Therapy, X-Ray, Radium 18: 327 June 1937  re Comment from Birch Point Medical Inc FDA 2000-N-0158-0011",Supporting & Related Material,Background Material,2014-09-08T04:00:00Z,2014,9,,,2014-09-08T20:18:01Z,,0,0,09000064804d174c
FDA-2000-N-0158-0015,FDA,FDA-2000-N-0158,Attachment 4 Affidavit of Luther C. Kloth re Comment from Birch Point Medical Inc FDA 2000-N-0158-0011,Supporting & Related Material,Background Material,2014-09-05T04:00:00Z,2014,9,,,2014-09-05T20:37:58Z,,0,0,09000064804d175c
FDA-2000-N-0158-0020,FDA,FDA-2000-N-0158,Attachment 9  Advertisement: TECA SP-5 1953 re Comment from Birch Point Medical Inc,Supporting & Related Material,Background Material,2014-09-05T04:00:00Z,2014,9,,,2014-09-05T20:38:30Z,,0,0,09000064804d172d
FDA-2000-N-0158-0018,FDA,FDA-2000-N-0158,Attachment 7 Affidavit of  Danny D.Smith re Comment from Birch Point Medical Inc FDA 2000-N-0158-0011,Supporting & Related Material,Background Material,2014-09-05T04:00:00Z,2014,9,,,2014-09-05T20:17:10Z,,0,0,09000064804d1758
FDA-2000-N-0158-0013,FDA,FDA-2000-N-0158,"Attachment 2 American Medical Association, Handbook of Physical Therapy 3d ed. 1939 re Comment from Birch Point Medical Inc FDA 2000-N-0158- 0011",Supporting & Related Material,Background Material,2014-09-05T04:00:00Z,2014,9,,,2014-09-05T20:36:19Z,,0,0,09000064804d1760
FDA-2000-N-0158-0021,FDA,FDA-2000-N-0158,Attachment 10 Advertisement: TECA SP-2 1954 re Comment from Birch Point Medical Inc re FDA 2000-N-0158-0011,Supporting & Related Material,Background Material,2014-09-05T04:00:00Z,2014,9,,,2014-09-05T20:34:09Z,,0,0,09000064804d1740
FDA-2000-N-0158-0022,FDA,FDA-2000-N-0158,Attachment 11 Advertisement TECA CD4 P5 1958 re Comment from Birch Point Medical Inc FDA 2000-N-0158- 0011,Supporting & Related Material,Background Material,2014-09-05T04:00:00Z,2014,9,,,2014-09-05T20:47:31Z,,0,0,09000064804d1741
FDA-2000-N-0158-0019,FDA,FDA-2000-N-0158,Attachment 8 Merck Brochure for Mecholyl 1941 re Comment from Birch Point Medical Inc FDA 2000-N-0158-0011,Supporting & Related Material,Background Material,2014-09-05T04:00:00Z,2014,9,,,2014-09-05T20:24:29Z,,0,0,09000064804d1756
FDA-2000-N-0158-0024,FDA,FDA-2000-N-0158,"Attachment 13 Advertisement PC 1118,  PC 1120  1958 re Comment from Birch Point Medical Inc FDA 2000-N-0158-0011",Supporting & Related Material,Background Material,2014-09-05T04:00:00Z,2014,9,,,2014-09-05T21:00:52Z,,0,0,09000064804d1745
FDA-2000-N-0158-0012,FDA,FDA-2000-N-0158,Attachment 1 Advertisement PC 2918 2919 2900 2901 1963 re Comment from Birch Point Medical Inc FDA-2000-N-0158-0011,Supporting & Related Material,Background Material,2014-09-05T04:00:00Z,2014,9,,,2014-09-05T20:35:46Z,,0,0,09000064804d1765
FDA-2000-N-0158-0017,FDA,FDA-2000-N-0158,Attachment 6 Affidavit of Neil I. Spielholz re Comment from Birch Point Medical Inc FDA 2000-N-0158-0011,Supporting & Related Material,Background Material,2014-09-05T04:00:00Z,2014,9,,,2014-09-05T20:09:49Z,,0,0,09000064804d1759
FDA-2000-N-0158-0023,FDA,FDA-2000-N-0158,Attachment 12  Advertisement TOMAC 1958 re Comment from Birch Point Medical Inc FDA 2000-N-0158-0011,Supporting & Related Material,Background Material,2014-09-05T04:00:00Z,2014,9,,,2014-09-05T20:53:54Z,,0,0,09000064804d1743
FDA-2000-N-0158-0016,FDA,FDA-2000-N-0158,"Attachment 5 Joseph Kahn, Principles and Practice of Electrotherapy 1987 excerpt re Comment from Birch Point Medical Inc FDA 2000-N-0158-0011",Supporting & Related Material,Background Material,2014-09-05T04:00:00Z,2014,9,,,2014-09-05T20:38:13Z,,0,0,09000064804d175b
FDA-2000-N-0158-0014,FDA,FDA-2000-N-0158,"Attachment 3 Linda Amrein et al., "" Use of Low Voltage Electrotherapy and Electromyography in Physical Therapy, '' Physical Therapy 51/12: 1283 1971 re Comment from Birch Point Medical Inc FDA 2000-N-0158-0011",Supporting & Related Material,Background Material,2014-09-05T04:00:00Z,2014,9,,,2014-09-05T20:37:11Z,,0,0,09000064804d175e
FDA-2000-N-0158-0006,FDA,FDA-2000-N-0158,"Memorandum from FDA/CDRH Extension of Comment Period to December 19, 2000 (Physical Medicine Devices; Revision of the Identification of the Ionotophoresis Device), dated October 27, 2000",Other,Memorandum,2014-09-03T04:00:00Z,2014,9,2014-09-03T04:00:00Z,,2024-10-29T19:51:32Z,,0,0,09000064804d1723
FDA-2000-N-0158-0010,FDA,FDA-2000-N-0158,"Shipping Label re Comment from IOMED Inc., FDA-2000-N-0158-0009",Supporting & Related Material,Background Material,2014-08-20T04:00:00Z,2014,8,,,2014-09-03T18:10:08Z,,0,0,09000064804d172c
FDA-2000-N-0158-0005,FDA,FDA-2000-N-0158,"Enclosure  re Comment from Wescor Inc, FDA-2000-N-0158-0004",Supporting & Related Material,Background Material,2014-08-20T04:00:00Z,2014,8,,,2014-09-03T18:09:50Z,,0,0,09000064804d171f
FDA-2000-N-0158-0008,FDA,FDA-2000-N-0158,Enclosure 1 re Comment from Cystic Fibrosis Foundation (CFF) FDA-2000-N-0158-0007,Supporting & Related Material,Background Material,2014-08-20T04:00:00Z,2014,8,,,2014-09-03T18:09:59Z,,0,0,09000064804d1726
FDA-2000-N-0158-0002,FDA,FDA-2000-N-0158,Medical Devices; Reclassification of the lontophoresis Device,Notice,Notice of Intent,2004-11-04T05:00:00Z,2004,11,2004-11-04T05:00:00Z,2005-02-03T04:59:59Z,2025-06-11T23:54:22Z,04-24591,0,0,09000064804d178a
FDA-2000-N-0158-0003,FDA,FDA-2000-N-0158,Medical Devices; Revision of the Identification of the lontophoresis Device; Withdrawal,Notice,Withdrawal,2004-11-04T05:00:00Z,2004,11,2004-11-04T05:00:00Z,,2025-06-11T23:55:13Z,04-24590,0,0,09000064804d178b
FDA-2000-N-0158-0001,FDA,FDA-2000-N-0158,Physical Medicine Devices; Revision of the Identification of the Ionotophoresis Device,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2000-09-01T04:00:00Z,2000,9,2000-08-22T04:00:00Z,2000-11-21T04:59:59Z,2025-06-11T23:53:28Z,00-21251,0,0,09000064804d1701