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
Jul 19, 2024
Wireless TENS & EMS (Model SM9110,SM9113,SM9116)
Chongqing Rob Linka Science and Technology Co., Ltd.
Neurology
297d
Cleared
Jun 27, 2024
TENS&EMS units (SM9109A, SM9109B)
Plexus Yoga, LLC Dba Chirp
Neurology
30d
Cleared
Mar 27, 2024
Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)
Wuxi Jiajian Medical Instrument Co., Ltd.
Neurology
315d
Cleared
Mar 25, 2024
Transcutaneous Electrical Nerve Stimulator (9029SCM)
Hong Kong Etech Groups Limited
Neurology
53d
Cleared
Mar 21, 2024
Electrical Stimulator System
Gymmax Technology Shenzen Co., Ltd.
Neurology
220d
Cleared
Mar 01, 2024
Muscle Stimulator
Shenzhen Yiran Intelligent Co., Ltd.
Neurology
270d
Cleared
Mar 01, 2024
S21 OTC Transcutaneous Electrical Nerve Stimulator
Micro Current Technology, Inc.
Neurology
157d
Cleared
Feb 23, 2024
ENSO (Model 2)
Hinge Health, Inc.
Neurology
88d
Cleared
Feb 12, 2024
EMS/TENS Massager Device
Shenzhen Imdk Medical Technology Co., Ltd.
Physical Medicine
140d
Cleared
Feb 12, 2024
Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)
Chongqing Rob Linka Science and Technology Co., Ltd.
Neurology
139d
Cleared
Jan 22, 2024
Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)
Shenzhen Roundwhale Technology Co. , Ltd.
Neurology
250d
Cleared
Jan 19, 2024
Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)
Hi-Dow International, Inc.
Neurology
88d
Cleared
Dec 15, 2023
Ova+ (K-OVAP-USA)
Tenscare, Ltd.
Neurology
256d
Cleared
Dec 08, 2023
Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412)
Shenzhen Kentro Medical Electronics Co., Ltd.
Neurology
112d
Cleared
Nov 03, 2023
ManaFlexx 2 (model: MF002-RX, MF002-OTC)
Manamed, Inc.
Neurology
156d
Cleared
Oct 05, 2023
Heating Tens, FT-615
Hivox Biotek, Inc.
Neurology
34d
Cleared
Aug 18, 2023
Unicare (K-UNICARE-USA)
Tenscare, Ltd.
Neurology
127d
Cleared
Jul 19, 2023
Nu-beca Transcutaneous Electrical Nerve Stimulation
Nu-Beca & Maxcellent Co.
Neurology
287d
Cleared
May 22, 2023
TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)
Jiangxi Royall Smart Technology Co., Ltd.
Neurology
90d
Cleared
May 13, 2023
HEATING TENS/EMS, FT-810R
Hivox Biotek, Inc.
Neurology
197d
Cleared
May 10, 2023
Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039
Shenzhen Kentro Medical Electronics Co., Ltd.
Neurology
230d
Cleared
May 09, 2023
Tens & Ems Device
Shenzhen Jian Feng Electronic Technology Co., Ltd.
Physical Medicine
139d
Cleared
May 08, 2023
Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A)
Shenzhen Leqing Medical Instrument Co., Ltd.
Neurology
175d
Cleared
Apr 26, 2023
TENS7000 Rechargeable (Model:TENS7000 Rechargeable)
Chongqing Rob Linka Science and Technology Co., Ltd.
Neurology
30d