Product code NUH— Neurology
Electronic Pulse Stimulator
- Classification name
- Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Total cleared
- 229
- First cleared
- Most recent
FDA classification definition
“TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES”
Market context for product code NUH
FDA has cleared devices under product code NUH between 2004 and 2026, filed by 119 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
Top applicants under product code NUH
- Everyway Medical Instruments Co.,Ltd
- Well-Life Healthcare Limited
- Hivox Biotek, Inc.
- Shenzhen Kentro Medical Electronics Co., Ltd.
- Omron Healthcare, Inc.
- Shenzhen Dongdixin Technology Co., Ltd.
- Shenzhen Osto Technology Company Limited
- Shenzhen Osto Technology Co., Ltd.
- Hong Qiangxing (Shenzhen) Electronics Limited
- Shenzhen Jian Feng Electronic Technology Co., Ltd.
Recent clearances under product code NUH
1–100 of 229- K260412 — TENS 7000 Rechargeable 4 Channel (TENS 7000H)
- K260425 — TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)
- K253896 — TENS/EMS device (GUSE01)
- K253305 — TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)
- K251958 — VEINOPLUS Back
- K253740 — TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
- K252688 — Transcutaneous Electrical Nerve Stimulator (RJTENS-2)
- K251856 — Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4
- K243131 — Triathlon Pro
- K251429 — OTC 4-Channel Rechargeable TENS Unit
- K250784 — Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122)
- K251187 — 3 in 1 TENS UNIT (TC1241, TC2241, TS1241)
- K243856 — TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026)
- K250360 — TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026)
- K250053 — TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)
- K243613 — Patch-TEA (Model TRI-21)
- K250033 — Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)
- K242460 — Progenix Select Stim
- K242815 — POCKET TENS (EP-300)
- K243334 — Nooro Body & Foot Stimulator (SM9141, SM9142)
- K242332 — Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494)
- K242567 — Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C)
- K233054 — Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator +3 more
- K241678 — TENS & EMS Stimulator (MHD-1083)
- K241365 — Pixie Pulse (SM9068)
- K241119 — Transcutaneous Electrical Nerve Stimulator (K6106)
- K233067 — Wireless TENS & EMS (Model SM9110,SM9113,SM9116)
- K241509 — TENS&EMS units (SM9109A, SM9109B)
- K231425 — Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)
- K240292 — Transcutaneous Electrical Nerve Stimulator (9029SCM)
- K232439 — Electrical Stimulator System
- K231648 — Muscle Stimulator
- K233095 — S21 OTC Transcutaneous Electrical Nerve Stimulator
- K233784 — ENSO (Model 2)
- K233040 — EMS/TENS Massager Device
- K233092 — Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)
- K231423 — Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)
- K233461 — Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)
- K230926 — Ova+ (K-OVAP-USA)
- K232517 — Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412)
- K231569 — ManaFlexx 2 (model: MF002-RX, MF002-OTC)
- K232675 — Heating Tens, FT-615
- K231053 — Unicare (K-UNICARE-USA)
- K223151 — Nu-beca Transcutaneous Electrical Nerve Stimulation
- K230443 — TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)
- K223308 — HEATING TENS/EMS, FT-810R
- K222870 — 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
- K223825 — Tens & Ems Device
- K223428 — 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)
- K230829 — TENS7000 Rechargeable (Model:TENS7000 Rechargeable)
- K230164 — TENS and EMS Stimulation (OTC)
- K230163 — TENS and EMS Stimulation (OTC)
- K230174 — TENS and EMS Stimulation (OTC)
- K222867 — AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)
- K222488 — Everyway Analog OTC TENS
- K221992 — Electronic Pulse Stimulator
- K221092 — Transcutaneous Electrical Nerve Stimulator Model: ST-304
- K220997 — Wireless TENS/EMS, Bruno, Aela
- K220998 — Transcutaneous Electrical Nerve Stimulator, Model: KTR-405
- K220524 — Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)
- K221251 — Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)
- K220573 — Noodle
- K221384 — Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2
- K213788 — TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)
- K220283 — TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)
- K220152 — TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)
- K212377 — Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01
- K212184 — TENS and EMS Stimulation (OTC)
- K220005 — TENS & PMS Unit
- K213741 — TENS & EMS DEVICE (Model: FM-B2403A)
- K213835 — TENS & EMS Device
- K213091 — Well-Life TENS/EMS/Heating Stimulator
- K220150 — TENS & PMS (Model: SM9126)
- K211263 — Intrelief
- K212285 — Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)
- K210223 — Transcutaneous Electrical Nerve Stimulator
- K212918 — Heat StimPlus
- K212989 — Low-frequency Stimulator (Model: AST-645, AST-646)
- K202671 — DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)
- K211403 — HIVOX OTC Electrical Stimulator, FT610-B
- K200558 — Smart Neck Stimulator
- K211736 — Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)
- K210756 — Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H
- K200694 — Perfect EMS
- K202866 — TENS & EMS Device
- K200177 — Low-frequency Multi-function physiotherapy instrument
- K203574 — HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2
- K202849 — Everyway Analog OTC TENS, model N103A/N302
- K202470 — Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300
- K202317 — Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806
- K201335 — Li-Battery powered OTC TENS/EMS Combination Stimulator
- K200237 — Transcutaneous Electronic Nerve Stimulator
- K191982 — Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)
- K193655 — MSLS6QF TENS/PMS Device
- K200838 — Tyece OTC TENS Model
- K200561 — StimPlus Patch, StimPlus Patch, StimPlus Patch
- K200354 — Electronic stimulator
- K200727 — TENS and Muscle Stimulator
- K192201 — Electrical Stimulator System
- K183110 — LIVIA
Data sourced from openFDA. This site is unofficial and independent of the FDA.