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
121–144 of 227
Cleared Nov 21, 2018
PlayMakar Sport Muscle Stimulator, Model PRO-500
K182581
Playmakar, Inc.
Neurology · 63d
Cleared Nov 09, 2018
Heat Pain Pro
K181992
Omron Healthcare, Inc.
Neurology · 106d
Cleared Oct 26, 2018
A6 OTC Pain Relief TENS
K182753
Everyway Medical Instruments Co.,Ltd
Neurology · 28d
Cleared Oct 26, 2018
V2 OTC Pain Relief TENS
K182767
Everyway Medical Instruments Co.,Ltd
Neurology · 28d
Cleared Sep 26, 2018
Everyway Wireless TENS & EMS Unit
K181707
Everyway Medical Instruments Co.,Ltd
Neurology · 90d
Cleared Sep 15, 2018
ThermaCare Quick Therapy TENS
K181102
Pfizer, Inc.
Neurology · 142d
Cleared Sep 06, 2018
Dual output digital therapy massager
K172834
Shenzhen Osto Technology Co., Ltd.
Neurology · 352d
Cleared Aug 10, 2018
iStim S2 OTC Pain Relief TENS
K181849
Everyway Medical Instruments Co., Ldt.
Neurology · 30d
Cleared Jul 08, 2018
BMLS16-1
K172971
Biomedical Life Systems, Inc.
Neurology · 285d
Cleared Jun 22, 2018
Wireless Pain Relieve Device
K180331
Shenzhen Dongdixin Technology Co., Ltd.
Neurology · 136d
Cleared Jun 07, 2018
Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator
K180956
Shenzhen Roundwhale Technology Co. , Ltd.
Neurology · 56d
Cleared Jun 06, 2018
Balego TENS Digital Edition with Accessories for Pain Relief (OTC)
K181207
Everyway Medical Instruments Co., Ldt.
Neurology · 30d
Cleared Apr 19, 2018
EV-804 OTC Pain Relief TENS
K172919
Everyway Medical Instruments Co.,Ltd
Neurology · 206d
Cleared Mar 07, 2018
ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
K171802
Bayer Healthcare, LLC
Neurology · 261d