Everelife Transcutaneous Muscle Stimulator

FDA 510(k) K071624 · Everlife Medical Equipment Co., Ltd.

Substantially Equivalent

510(k) numberK071624

Submission

Device name
Everelife Transcutaneous Muscle Stimulator
Applicant
Everlife Medical Equipment Co., Ltd.
Hsin-Chu City, TW
Received
June 14, 2007
Decision date
November 27, 2007
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

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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
K071320Everlife Powered Muscle Stimulator, Model E-100204, E-100504, E-100509, E-100804…IPF · Traditional 08/17/2007SE
K070890Everlife Interferential Current Therapy, Model IF-100507LIH · Traditional 06/29/2007SE

Questions and answers

When was Everelife Transcutaneous Muscle Stimulator cleared by the FDA?

Everelife Transcutaneous Muscle Stimulator (K071624) received a 510(k) decision of Substantially Equivalent on November 27, 2007, 166 days after the submission was received.

What is the product code of K071624?

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