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 Well-Life Healthcare Limited, Hivox Biotek, Inc. and Changsha Anxiang Medical Technology Co., Ltd..

227
Total
227
Cleared
180d
Avg days
2004
Since
227 devices
25–48 of 227
Cleared Jul 19, 2024
Wireless TENS & EMS (Model SM9110,SM9113,SM9116)
K233067
Chongqing Rob Linka Science and Technology Co., Ltd.
Neurology · 297d
Cleared Jun 27, 2024
TENS&EMS units (SM9109A, SM9109B)
K241509
Plexus Yoga, LLC Dba Chirp
Neurology · 30d
Cleared Mar 27, 2024
Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)
K231425
Wuxi Jiajian Medical Instrument Co., Ltd.
Neurology · 315d
Cleared Mar 25, 2024
Transcutaneous Electrical Nerve Stimulator (9029SCM)
K240292
Hong Kong Etech Groups Limited
Neurology · 53d
Cleared Mar 21, 2024
Electrical Stimulator System
K232439
Gymmax Technology Shenzen Co., Ltd.
Neurology · 220d
Cleared Mar 01, 2024
Muscle Stimulator
K231648
Shenzhen Yiran Intelligent Co., Ltd.
Neurology · 270d
Cleared Mar 01, 2024
S21 OTC Transcutaneous Electrical Nerve Stimulator
K233095
Micro Current Technology, Inc.
Neurology · 157d
Cleared Feb 23, 2024
ENSO (Model 2)
K233784
Hinge Health, Inc.
Neurology · 88d
Cleared Feb 12, 2024
EMS/TENS Massager Device
K233040
Shenzhen Imdk Medical Technology Co., Ltd.
Physical Medicine · 140d
Cleared Feb 12, 2024
Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)
K233092
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)
K231423
Shenzhen Roundwhale Technology Co. , Ltd.
Neurology · 250d
Cleared Jan 19, 2024
Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)
K233461
Hi-Dow International, Inc.
Neurology · 88d
Cleared Dec 15, 2023
Ova+ (K-OVAP-USA)
K230926
Tenscare, Ltd.
Neurology · 256d
Cleared Oct 05, 2023
Heating Tens, FT-615
K232675
Hivox Biotek, Inc.
Neurology · 34d
Cleared Aug 18, 2023
Unicare (K-UNICARE-USA)
K231053
Tenscare, Ltd.
Neurology · 127d
Cleared May 13, 2023
HEATING TENS/EMS, FT-810R
K223308
Hivox Biotek, Inc.
Neurology · 197d
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 Aug 04, 2022
Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)
K220524
Well-Life Healthcare Limited
Neurology · 162d
Cleared Feb 19, 2022
Well-Life TENS/EMS/Heating Stimulator
K213091
Well-Life Healthcare Limited
Neurology · 148d