V TENS Plus

Q: When was V TENS Plus cleared by the FDA?

V TENS Plus (K022731) received a 510(k) decision of Substantially Equivalent on November 14, 2002, 90 days after the submission was received.

Q: What is the product code of K022731?

The FDA product code is GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.

FDA 510(k) K022731 · Body Clock Health Care, Ltd.

Substantially Equivalent

510(k) numberK022731

Submission

Device name: V TENS Plus
Applicant: Body Clock Health Care, Ltd.
London, England, GB
Received: August 16, 2002
Decision date: November 14, 2002
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.5890
Specialty: Neurology

Other 510(k)s with product code GZJ

510(k)	Device	Applicant	Decision
K252712	STIMPOD NMS460 Nerve StimulatorGZJ · Traditional	Algiamed Technologies USA, Inc.	05/28/2026SE
K252767	actiTENS miniGZJ · Traditional	Sublimed	01/16/2026SE
K252236	CP Relief Wand Rx - TENS/NMESGZJ · Special	N & C Holdings, LLC	08/15/2025SE
K232441	Unipro (K-UNIPRO-US)GZJ · Traditional	Tenscare, Ltd.	08/30/2024SE
K241228	TENSWaveGZJ · Abbreviated	Zynex Medical Officer	08/27/2024SE
K233046	Electrical Neuromuscular Stimulator, Cure TrioGZJ · Traditional	Oriental Inspiration Limited	04/19/2024SE
K222879	Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)GZJ · Traditional	Wuxi Jiajian Medical Instrument Co., Ltd.	01/24/2023SE
K212618	iRelieve Microcurrent Pain Relief SystemGZJ · Traditional	Fast Track Technologies, Inc.	09/14/2022SE
K213802	StimOnTM Pain Relief System (GM2439)GZJ · Traditional	Gimer Medical Co., Ltd.	08/26/2022SE
K220578	Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)GZJ · Traditional	Bozhou Rongjian Medical Appliance Co., Ltd.	05/25/2022SE

More from Bozhou Rongjian Medical Appliance Co., Ltd.

510(k)	Device	Decision
K091045	Smart TENS, Model: D-BC05TGZJ · Traditional	12/18/2009SE
K041359	Body Clock Stimplus and Stimplus ProGZJ · Traditional	08/20/2004SE
K022849	Body Clock TENS N' ToneGZJ · Traditional	05/20/2003SE
K021846	804SIII; 804W; Libra TENS; 410; S-Tens IIGZJ · Traditional	11/22/2002SE
K022493	EMS 400IPF · Traditional	10/11/2002SE
K022076	First Choice & First Choice PlusGZJ · Traditional	09/24/2002SE

Questions and answers

When was V TENS Plus cleared by the FDA?

V TENS Plus (K022731) received a 510(k) decision of Substantially Equivalent on November 14, 2002, 90 days after the submission was received.

What is the product code of K022731?

The FDA product code is GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.