FDA Product Code NUH: Stimulator, Nerve, Transcutaneous, Over-the-counter
Over-the-counter nerve stimulators bring pain relief technology to the consumer market. FDA product code NUH covers transcutaneous electrical nerve stimulators available without a prescription.
These devices deliver low-level electrical impulses through skin electrodes to modulate pain signals for the temporary relief of sore or aching muscles. OTC TENS units are cleared for self-treatment of minor musculoskeletal pain in home settings.
NUH devices are Class II medical devices, regulated under 21 CFR 882.5890 and reviewed by the FDA Neurology panel.
Leading manufacturers include Everyway Medical Instruments Co.,Ltd, Shenzhen Kentro Medical Electronics Co., Ltd. and Hivox Biotek, Inc..
227
Total
227
Cleared
180d
Avg days
2004
Since
227 devices
Cleared
Dec 22, 2021
Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)
Oriental Inspiration Limited
Neurology
154d
Cleared
Dec 15, 2021
Transcutaneous Electrical Nerve Stimulator
Top-Rank Health Care Co., Ltd.
Neurology
321d
Cleared
Dec 13, 2021
Heat StimPlus
Famidoc Technology Co., Ltd.
Neurology
90d
Cleared
Nov 22, 2021
Low-frequency Stimulator (Model: AST-645, AST-646)
Shenzhen Osto Technology Co., Ltd.
Neurology
63d
Cleared
Nov 12, 2021
DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)
Guangzhou Xinbo Electronic Co., Ltd.
Physical Medicine
424d
Cleared
Oct 15, 2021
HIVOX OTC Electrical Stimulator, FT610-B
Hivox Biotek, Inc.
Neurology
162d
Cleared
Oct 04, 2021
Smart Neck Stimulator
Guandong Skg Intelligent Technology Co., Ltd.
Neurology
580d
Cleared
Sep 05, 2021
Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)
Shenzhen Osto Technology Company Limited
Neurology
90d
Cleared
Jun 11, 2021
Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H
Shenzhen Osto Technology Company Limited
Neurology
88d
Cleared
Jun 04, 2021
Perfect EMS
Tenscare, Ltd.
Neurology
444d
Cleared
May 19, 2021
TENS & EMS Device
Shenzhen Jian Feng Electronic Technology Co., Ltd.
Physical Medicine
233d
Cleared
Mar 25, 2021
Low-frequency Multi-function physiotherapy instrument
Shenzhen Kentro Medical Electronics Co., Ltd.
Neurology
426d
Cleared
Mar 10, 2021
HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2
Hivox Biotek, Inc.
Neurology
93d
Cleared
Dec 22, 2020
Everyway Analog OTC TENS, model N103A/N302
Everyway Medical Instruments Co.,Ltd
Neurology
85d
Cleared
Nov 25, 2020
Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300
Everyway Medical Instruments Co.,Ltd
Neurology
89d
Cleared
Nov 13, 2020
Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806
Everyway Medical Instruments Co.,Ltd
Neurology
88d
Cleared
Oct 24, 2020
Li-Battery powered OTC TENS/EMS Combination Stimulator
Everyway Medical Instruments Co.,Ltd
Neurology
157d
Cleared
Oct 19, 2020
Transcutaneous Electronic Nerve Stimulator
Shenzhen Kentro Medical Electronics Co., Ltd.
Neurology
269d
Cleared
Sep 25, 2020
Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)
Shenzhen Kentro Medical Electronics Co., Ltd.
Neurology
428d
Cleared
Sep 04, 2020
MSLS6QF TENS/PMS Device
Self Doctor Care, LLC
Neurology
249d
Cleared
Aug 12, 2020
Tyece OTC TENS Model
Tyece Limited
Neurology
134d
Cleared
Jul 01, 2020
StimPlus Patch, StimPlus Patch, StimPlus Patch
Jkh Health Co., Ltd.
Neurology
119d
Cleared
Jun 29, 2020
Electronic stimulator
Shenzhen Dongjilian Electronics Co., Ltd.
Neurology
137d
Cleared
Jun 18, 2020
TENS and Muscle Stimulator
Shenzhen Astec Technology Co., Ltd.
Neurology
90d