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2014-07-03
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Medical Devices; Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator to Treat Headache
Rules and Regulations
D09002ee1bdc4043a
D09002ee1bdc404b9
United States
Department of Health and Human Services
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org
United States Government Agency or Subagency
United States
Food and Drug Administration
originator
org
United States Government Agency or Subagency
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.
79 FR 37946
https://www.govinfo.gov/app/details/FR-2014-07-03/2014-15625
2014-15625
fr03jy14-7
4164-01-P
Docket No. FDA-2014-M-0799
https://www.govinfo.gov/app/details/FR-2014-07-03/2014-15625
https://www.govinfo.gov/content/pkg/FR-2014-07-03/html/2014-15625.htm
https://www.govinfo.gov/content/pkg/FR-2014-07-03/pdf/2014-15625.pdf
Medical Devices
Neurological Devices
3 p.
37946
37948
79 FR 37946
Code of Federal Regulations
Title 21 Part 882
21 CFR Part 882
Medical Devices; Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator to Treat Headache; Federal Register Vol. 79, Issue
RULE
2014-15625
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2014-08-04
Docket No. FDA-2014-M-0799
4164-01-P
2014-15625
Final order.
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.
This order is effective August 4, 2014. The classification was applicable on March 11, 2014.
Michael Hoffmann, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1434, Silver Spring, MD 20993-0002, 301- 796-6476, michael.hoffmann@fda.hhs.gov.
Medical Devices
Neurological Devices
Medical Devices:
Transcutaneous Electrical Nerve Stimulator to Treat Headache; Classification
,
michael.hoffmann@fda.hhs.gov
http://www.regulations.gov
Federal Register
Vol. 79, no. 128
Office of the Federal Register, National Archives and Records Administration
2014-07-03
continuing
daily
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329 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2014-07-03
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0042-1219
0364-1406
769-004-00000-9
000582072
f:fr03jy14
https://www.govinfo.gov/app/details/FR-2014-07-03
https://www.govinfo.gov/content/pkg/FR-2014-07-03/pdf/FR-2014-07-03.pdf
https://www.govinfo.gov/content/pkg/FR-2014-07-03/xml/FR-2014-07-03.xml
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DGPO
2014-07-03
2023-04-29
FR-2014-07-03
machine generated
eng
FR
FR-2014-07-03
79
128