federal_register: 2014-15625
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2014-15625 | Medical Devices; Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator to Treat Headache | Rule | The Food and Drug Administration (FDA) is classifying the transcutaneous electrical nerve stimulator to treat headache into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the transcutaneous electrical nerve stimulator to treat headache classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. | 2014-07-03 | 2014 | 7 | https://www.federalregister.gov/documents/2014/07/03/2014-15625/medical-devices-neurological-devices-classification-of-the-transcutaneous-electrical-nerve | https://www.govinfo.gov/content/pkg/FR-2014-07-03/pdf/2014-15625.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is classifying the transcutaneous electrical nerve stimulator to treat headache into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part... |