Medical Devices; Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator to Treat Headache
fda-device · Food and Drug Administration · Rule · Published 2014-07-03 · Effective 2014-08-04 · 79 FR 37946
Document
Document number
2014-15625
Federal Register citation
79 FR 37946
CFR reference
21 CFR 882
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2014-07-03
Effective date
2014-08-04
HHS docket
Docket No. FDA-2014-M-0799
Abstract
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.