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, Well-Life Healthcare Limited and Hivox Biotek, Inc..
229
Total
229
Cleared
180d
Avg days
2004
Since
229 devices
Cleared
Dec 07, 2018
Neck Care Therapy, Model: SYK 509B
Shenzhen Osto Technology Co., Ltd.
Neurology
441d
Cleared
Nov 26, 2018
Low-frequency Multi-function physiotherapy instrument
Shenzhen Osto Technology Co., Ltd.
Neurology
433d
Cleared
Nov 21, 2018
PlayMakar Sport Muscle Stimulator, Model PRO-500
Playmakar, Inc.
Neurology
63d
Cleared
Nov 09, 2018
Heat Pain Pro
Omron Healthcare, Inc.
Neurology
106d
Cleared
Oct 26, 2018
A6 OTC Pain Relief TENS
Everyway Medical Instruments Co.,Ltd
Neurology
28d
Cleared
Oct 26, 2018
V2 OTC Pain Relief TENS
Everyway Medical Instruments Co.,Ltd
Neurology
28d
Cleared
Sep 26, 2018
Everyway Wireless TENS & EMS Unit
Everyway Medical Instruments Co.,Ltd
Neurology
90d
Cleared
Sep 15, 2018
ThermaCare Quick Therapy TENS
Pfizer, Inc.
Neurology
142d
Cleared
Sep 06, 2018
Dual output digital therapy massager
Shenzhen Osto Technology Co., Ltd.
Neurology
352d
Cleared
Aug 10, 2018
iStim S2 OTC Pain Relief TENS
Everyway Medical Instruments Co., Ldt.
Neurology
30d
Cleared
Jul 08, 2018
BMLS16-1
Biomedical Life Systems, Inc.
Neurology
285d
Cleared
Jun 22, 2018
Wireless Pain Relieve Device
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
Shenzhen Roundwhale Technology Co. , Ltd.
Neurology
56d
Cleared
Jun 06, 2018
Balego TENS Digital Edition with Accessories for Pain Relief (OTC)
Everyway Medical Instruments Co., Ldt.
Neurology
30d
Cleared
Apr 19, 2018
EV-804 OTC Pain Relief TENS
Everyway Medical Instruments Co.,Ltd
Neurology
206d
Cleared
Mar 07, 2018
ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
Bayer Healthcare, LLC
Neurology
261d
Cleared
Dec 08, 2017
Wireless Pain Relieve Device Model: LT5018C
Shenzhen Dongdixin Technology Co., Ltd.
Neurology
30d
Cleared
Nov 29, 2017
HIVOX OTC Electrical Stimulator
Hivox Biotek, Inc.
Neurology
163d
Cleared
Nov 17, 2017
Dr.MUSIC 3s
Smartmedicaldevice Co., Ltd.
Neurology
95d
Cleared
Nov 01, 2017
Mytens Model: BW-TSX
Bewell Connect Corp.
Neurology
210d
Cleared
Oct 19, 2017
Avail
Omron Healthcare, Inc.
Neurology
101d
Cleared
Oct 18, 2017
OTC Combo TENS/EMS System
Well-Life Healthcare Limited
Neurology
30d
Cleared
Sep 22, 2017
WiTouch Pro, WiTouch, Neubac
Hollywog, LLC
Neurology
113d
Cleared
Sep 19, 2017
Pain Therapy Device
Guangzhou Xinbo Electronic Co., Ltd.
Neurology
271d