NUH · Class II · 21 CFR 882.5890

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
73–96 of 227
Cleared Dec 22, 2021
Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)
K212285
Oriental Inspiration Limited
Neurology · 154d
Cleared Dec 15, 2021
Transcutaneous Electrical Nerve Stimulator
K210223
Top-Rank Health Care Co., Ltd.
Neurology · 321d
Cleared Dec 13, 2021
Heat StimPlus
K212918
Famidoc Technology Co., Ltd.
Neurology · 90d
Cleared Nov 22, 2021
Low-frequency Stimulator (Model: AST-645, AST-646)
K212989
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)
K202671
Guangzhou Xinbo Electronic Co., Ltd.
Physical Medicine · 424d
Cleared Oct 15, 2021
HIVOX OTC Electrical Stimulator, FT610-B
K211403
Hivox Biotek, Inc.
Neurology · 162d
Cleared Oct 04, 2021
Smart Neck Stimulator
K200558
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)
K211736
Shenzhen Osto Technology Company Limited
Neurology · 90d
Cleared Jun 11, 2021
Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H
K210756
Shenzhen Osto Technology Company Limited
Neurology · 88d
Cleared Jun 04, 2021
Perfect EMS
K200694
Tenscare, Ltd.
Neurology · 444d
Cleared May 19, 2021
TENS & EMS Device
K202866
Shenzhen Jian Feng Electronic Technology Co., Ltd.
Physical Medicine · 233d
Cleared Mar 25, 2021
Low-frequency Multi-function physiotherapy instrument
K200177
Shenzhen Kentro Medical Electronics Co., Ltd.
Neurology · 426d
Cleared Mar 10, 2021
HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2
K203574
Hivox Biotek, Inc.
Neurology · 93d
Cleared Dec 22, 2020
Everyway Analog OTC TENS, model N103A/N302
K202849
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
K202470
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
K202317
Everyway Medical Instruments Co.,Ltd
Neurology · 88d
Cleared Oct 24, 2020
Li-Battery powered OTC TENS/EMS Combination Stimulator
K201335
Everyway Medical Instruments Co.,Ltd
Neurology · 157d
Cleared Oct 19, 2020
Transcutaneous Electronic Nerve Stimulator
K200237
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)
K191982
Shenzhen Kentro Medical Electronics Co., Ltd.
Neurology · 428d
Cleared Sep 04, 2020
MSLS6QF TENS/PMS Device
K193655
Self Doctor Care, LLC
Neurology · 249d
Cleared Aug 12, 2020
Tyece OTC TENS Model
K200838
Tyece Limited
Neurology · 134d
Cleared Jul 01, 2020
StimPlus Patch, StimPlus Patch, StimPlus Patch
K200561
Jkh Health Co., Ltd.
Neurology · 119d
Cleared Jun 29, 2020
Electronic stimulator
K200354
Shenzhen Dongjilian Electronics Co., Ltd.
Neurology · 137d
Cleared Jun 18, 2020
TENS and Muscle Stimulator
K200727
Shenzhen Astec Technology Co., Ltd.
Neurology · 90d