NUH · Stimulator, Nerve, Transcutaneous, Over-The-Counter

Device class

Class II

Regulation 882.5890

Total clearances

101

2020-03-14 → 2026-06-26

Last 12 months

Unique sponsors

Definition

What is Stimulator, Nerve, Transcutaneous, Over-The-Counter

TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

Classification details

Medical specialty

Neurology

Review panel

Regulation number

882.5890

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Shenzhen Kentro Medical Electronics Co., Ltd.	7	0	2024-11-05
Hivox Biotek, Inc.	7	1	2026-06-16
Everyway Medical Instruments Co.,Ltd	6	1	2025-11-21
Hong Qiangxing (Shenzhen) Electronics Limited	4	1	2025-12-23
Changsha Yuwen Medical Equipment Co., Ltd.	4	0	2023-04-10
Shenzhen Jian Feng Electronic Technology Co., Ltd.	4	0	2023-05-09
Shenzhen Osto Technology Company Limited	3	0	2021-09-05
Well-Life Healthcare Limited	3	0	2024-10-18
Changsha Anxiang Medical Technology Co., Ltd.	3	1	2025-08-28
Chongqing Rob Linka Science and Technology Co., Ltd.	3	0	2024-07-19
Shenzhen Jiantuo Electronics Co., Ltd.	3	1	2025-12-31
Tenscare, Ltd.	3	0	2023-12-15
Shenzhen Yicai Health Technology Co., Ltd.	2	0	2025-08-21
Gymmax Technology Shenzen Co., Ltd.	2	0	2024-03-21
Shenzhen Astec Technology Co., Ltd.	2	0	2025-05-29
Guangzhou Pinzhi Medical Technology Co., Ltd.	1	0	2025-04-07
Lifecare , Ltd.	1	0	2020-05-04
Globalcare Medical Technology Co., Ltd.	1	1	2026-03-04
Guandong Skg Intelligent Technology Co., Ltd.	1	0	2021-10-04
Plexus Yoga, LLC Dba Chirp	1	0	2024-06-27
Hi-Dow International, Inc.	1	0	2024-01-19
Manamed, Inc.	1	0	2023-11-03
Wuxi Jiajian Medical Instrument Co., Ltd.	1	0	2024-03-27
Ningbo Medkinetic Medical Device Co., Ltd.	1	0	2022-04-15
Progenix, LLC	1	0	2025-04-02

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
E0720	HCPCS	Transcutaneous electrical nerve stimulation (tens) device, two lead, localized stimulation ✓ CMS-verified description	High	Standard HCPCS code for transcutaneous electrical nerve stimulation (TENS) unit for pain relief
64550	CPT	—	Medium	CPT code for application of surface (transcutaneous) neurostimulation; initial treatment

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-06-26	K260412	Shenzhen Dongdixin Technology Co., Ltd.	TENS 7000 Rechargeable 4 Channel (TENS 7000H)
2026-06-16	K260425	Hivox Biotek, Inc.	TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)
2026-03-04	K253896	Globalcare Medical Technology Co., Ltd.	TENS/EMS device (GUSE01)
2025-12-31	K253305	Shenzhen Jiantuo Electronics Co., Ltd.	TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)
2025-12-23	K253740	Hong Qiangxing (Shenzhen) Electronics Limited	TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
2025-12-23	K251958	Dynapulse Medical	VEINOPLUS Back
2025-11-24	K252688	Bozhou Rongjian Medical Appliance Co., Ltd.	Transcutaneous Electrical Nerve Stimulator (RJTENS-2)
2025-11-21	K251856	Everyway Medical Instruments Co.,Ltd	Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4
2025-11-07	K243131	Sigma Biomedical	Triathlon Pro
2025-08-28	K251429	Changsha Anxiang Medical Technology Co., Ltd.	OTC 4-Channel Rechargeable TENS Unit
2025-08-21	K250784	Shenzhen Yicai Health Technology Co., Ltd.	Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122)
2025-07-28	K251187	Changsha Anxiang Medical Technology Co., Ltd.	3 in 1 TENS UNIT (TC1241, TC2241, TS1241)
2025-05-29	K243856	Shenzhen Astec Technology Co., Ltd.	TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026)
2025-05-11	K250360	Shenzhen Jiantuo Electronics Co., Ltd.	TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026)
2025-05-09	K250053	Shenzhen Jiantuo Electronics Co., Ltd.	TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)
2025-04-09	K243613	Transtimulation Research, Inc.	Patch-TEA (Model TRI-21)
2025-04-07	K250033	Guangzhou Pinzhi Medical Technology Co., Ltd.	Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)
2025-04-02	K242460	Progenix, LLC	Progenix Select Stim
2024-12-17	K242815	Hivox Biotek, Inc.	POCKET TENS (EP-300)
2024-11-22	K243334	Xf Agencija Limited	Nooro Body & Foot Stimulator (SM9141, SM9142)
2024-11-05	K242332	Shenzhen Kentro Medical Electronics Co., Ltd.	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)
2024-11-04	K242567	Changsha Anxiang Medical Technology Co., Ltd.	Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C)
2024-10-18	K233054	Well-Life Healthcare Limited	Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator
2024-09-09	K241678	Shenzhen Minghuangda Electronics Co., Ltd.	TENS & EMS Stimulator (MHD-1083)
2024-08-12	K241365	Pixie Cup, LLC	Pixie Pulse (SM9068)