Electronic Pulse Stimulator

Q: What is the product code of K221992?

The FDA product code is NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter, a Class II (moderate risk) device regulated under 21 CFR 882.5890.

FDA 510(k) K221992 · Beijing Choice Electronic Technology Co., Ltd.

Substantially Equivalent

510(k) numberK221992

Submission

Device name: Electronic Pulse Stimulator
Applicant: Beijing Choice Electronic Technology Co., Ltd.
Beijing, CN
Received: July 6, 2022
Decision date: October 21, 2022
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.5890
Specialty: Neurology

TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

Other 510(k)s with product code NUH

510(k)	Device	Applicant	Decision
K261131	Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J…NUH · Traditional	Shenzhen Osto Medical Technology Co.,Ltd	09/06/2026SE
K260412	TENS 7000 Rechargeable 4 Channel (TENS 7000H)NUH · Traditional	Shenzhen Dongdixin Technology Co., Ltd.	06/26/2026SE
K260425	TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)NUH · Traditional	Hivox Biotek, Inc.	06/16/2026SE
K253896	TENS/EMS device (GUSE01)NUH · Traditional	Globalcare Medical Technology Co., Ltd.	03/04/2026SE
K253305	TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)NUH · Traditional	Shenzhen Jiantuo Electronics Co., Ltd.	12/31/2025SE
K253740	Tens&Ems (HZ9151B, HZ9151C, HZ9151D)NUH · Traditional	Hong Qiangxing (Shenzhen) Electronics Limited	12/23/2025SE
K251958	VEINOPLUS BackNUH · Traditional	Dynapulse Medical	12/23/2025SE
K252688	Transcutaneous Electrical Nerve Stimulator (RJTENS-2)NUH · Traditional	Bozhou Rongjian Medical Appliance Co., Ltd.	11/24/2025SE
K251856	Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4NUH · Special	Everyway Medical Instruments Co.,Ltd	11/21/2025SE
K243131	Triathlon ProNUH · Traditional	Sigma Biomedical	11/07/2025SE

More from Sigma Biomedical

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K230172	Pulse OximeterDQA · Traditional	08/12/2023SE
K220101	Pulse OximeterDQA · Traditional	03/08/2023SE
K211400	Pulse OximeterDQA · Traditional	02/11/2022SE
K211752	Infrared ThermometerFLL · Traditional	01/21/2022SE
K211754	Vital Signs MonitorMWI · Traditional	11/15/2021SE
K181503	Fingertip Pulse OximeterDQA · Traditional	10/11/2018SE
K172366	Wrist Pulse OximeterDQA · Traditional	03/16/2018SE
K162089	Blood Pressure MonitorDXN · Traditional	02/10/2017SE

Questions and answers

When was Electronic Pulse Stimulator cleared by the FDA?

Electronic Pulse Stimulator (K221992) received a 510(k) decision of Substantially Equivalent on October 21, 2022, 107 days after the submission was received.

What is the product code of K221992?

The FDA product code is NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter, a Class II (moderate risk) device regulated under 21 CFR 882.5890.