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