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
49–72 of 227
Cleared Apr 10, 2023
TENS and EMS Stimulation (OTC)
K230164
Changsha Yuwen Medical Equipment Co., Ltd.
Physical Medicine · 80d
Cleared Mar 20, 2023
TENS and EMS Stimulation (OTC)
K230163
Changsha Yuwen Medical Equipment Co., Ltd.
Physical Medicine · 59d
Cleared Mar 20, 2023
TENS and EMS Stimulation (OTC)
K230174
Changsha Yuwen Medical Equipment Co., Ltd.
Physical Medicine · 59d
Cleared Dec 21, 2022
AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)
K222867
Andon Health Co, Ltd.
Neurology · 90d
Cleared Nov 15, 2022
Everyway Analog OTC TENS
K222488
Everyway Medical Instruments Co.,Ltd
Neurology · 90d
Cleared Oct 21, 2022
Electronic Pulse Stimulator
K221992
Beijing Choice Electronic Technology Co., Ltd.
Neurology · 107d
Cleared Sep 13, 2022
Transcutaneous Electrical Nerve Stimulator Model: ST-304
K221092
Shenzhen Future Electronic Co., Ltd.
Neurology · 153d
Cleared Sep 01, 2022
Wireless TENS/EMS, Bruno, Aela
K220997
Zmi Elecronics , Ltd.
Neurology · 150d
Cleared Aug 24, 2022
Transcutaneous Electrical Nerve Stimulator, Model: KTR-405
K220998
Shenzhen Kentro Medical Electronics Co., Ltd.
Physical Medicine · 142d
Cleared Aug 04, 2022
Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)
K220524
Well-Life Healthcare Limited
Neurology · 162d
Cleared Jul 29, 2022
Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)
K221251
Guangzhou Huakai Electronic Technology Co., Ltd.
Neurology · 88d
Cleared Jul 09, 2022
Noodle
K220573
Pourang Bral, Dds, LLC
Neurology · 131d
Cleared Jun 11, 2022
Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2
K221384
Hivox Biotek, Inc.
Neurology · 29d
Cleared May 06, 2022
TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)
K213788
Dongguan Bohuikang Technology Co.,Ltd
Neurology · 151d
Cleared May 02, 2022
TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)
K220283
Hong Qiangxing (Shenzhen) Electronics Limited
Neurology · 90d
Cleared Apr 19, 2022
TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)
K220152
Hong Qiangxing (Shenzhen) Electronics Limited
Neurology · 90d
Cleared Apr 15, 2022
Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01
K212377
Ningbo Medkinetic Medical Device Co., Ltd.
Neurology · 256d
Cleared Apr 01, 2022
TENS and EMS Stimulation (OTC)
K212184
Changsha Yuwen Medical Equipment Co., Ltd.
Neurology · 262d
Cleared Apr 01, 2022
TENS & PMS Unit
K220005
Shenzhen Yuehua Xinsen Technology Co., Ltd.
Neurology · 87d
Cleared Mar 08, 2022
TENS & EMS DEVICE (Model: FM-B2403A)
K213741
Shenzhen Jian Feng Electronic Technology Co., Ltd.
Physical Medicine · 99d
Cleared Mar 03, 2022
TENS & EMS Device
K213835
Shenzhen Jian Feng Electronic Technology Co., Ltd.
Physical Medicine · 84d
Cleared Feb 19, 2022
Well-Life TENS/EMS/Heating Stimulator
K213091
Well-Life Healthcare Limited
Neurology · 148d
Cleared Feb 17, 2022
TENS & PMS (Model: SM9126)
K220150
Hong Qiangxing (Shenzhen) Electronics Limited
Neurology · 29d
Cleared Dec 30, 2021
Intrelief
K211263
Easymed Instruments Co., Ltd.
Neurology · 248d