First Choice & First Choice Plus

FDA 510(k) K022076 · Body Clock Health Care, Ltd.

Substantially Equivalent

510(k) numberK022076

Submission

Device name
First Choice & First Choice Plus
Applicant
Body Clock Health Care, Ltd.
London, England, GB
Received
June 26, 2002
Decision date
September 24, 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)DeviceApplicantDecision
K252712STIMPOD NMS460 Nerve StimulatorGZJ · Traditional Algiamed Technologies USA, Inc.05/28/2026SE
K252767actiTENS miniGZJ · Traditional Sublimed01/16/2026SE
K252236CP Relief Wand Rx - TENS/NMESGZJ · Special N & C Holdings, LLC08/15/2025SE
K232441Unipro (K-UNIPRO-US)GZJ · Traditional Tenscare, Ltd.08/30/2024SE
K241228TENSWaveGZJ · Abbreviated Zynex Medical Officer08/27/2024SE
K233046Electrical Neuromuscular Stimulator, Cure TrioGZJ · Traditional Oriental Inspiration Limited04/19/2024SE
K222879Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)GZJ · Traditional Wuxi Jiajian Medical Instrument Co., Ltd.01/24/2023SE
K212618iRelieve Microcurrent Pain Relief SystemGZJ · Traditional Fast Track Technologies, Inc.09/14/2022SE
K213802StimOnTM Pain Relief System (GM2439)GZJ · Traditional Gimer Medical Co., Ltd.08/26/2022SE
K220578Transcutaneous 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)DeviceDecision
K091045Smart TENS, Model: D-BC05TGZJ · Traditional 12/18/2009SE
K041359Body Clock Stimplus and Stimplus ProGZJ · Traditional 08/20/2004SE
K022849Body Clock TENS N' ToneGZJ · Traditional 05/20/2003SE
K021846804SIII; 804W; Libra TENS; 410; S-Tens IIGZJ · Traditional 11/22/2002SE
K022731V TENS PlusGZJ · Traditional 11/14/2002SE
K022493EMS 400IPF · Traditional 10/11/2002SE

Questions and answers

When was First Choice & First Choice Plus cleared by the FDA?

First Choice & First Choice Plus (K022076) received a 510(k) decision of Substantially Equivalent on September 24, 2002, 90 days after the submission was received.

What is the product code of K022076?

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