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FDA 510(k)

Transcutaneous Electrical Nerve Stimulator

K-Number: K202893 · 2021-06-18

ApplicantWuxi Jiajian Medical Instrument Co., Ltd.
Decision Date2021-06-18
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Transcutaneous Electrical Nerve Stimulator is a medical device manufactured by Wuxi Jiajian Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2021-06-18 under approval number K202893. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Transcutaneous Electrical Nerve Stimulator?

Transcutaneous Electrical Nerve Stimulator is a medical device that received FDA 510(k) clearance on 2021-06-18. It is manufactured by Wuxi Jiajian Medical Instrument Co., Ltd.. The 510(k) number is K202893.

When was Transcutaneous Electrical Nerve Stimulator approved by the FDA?

Transcutaneous Electrical Nerve Stimulator received FDA 510(k) clearance on 2021-06-18, under approval number K202893.

What company makes Transcutaneous Electrical Nerve Stimulator?

Transcutaneous Electrical Nerve Stimulator is manufactured by Wuxi Jiajian Medical Instrument Co., Ltd..

What is the FDA product code for Transcutaneous Electrical Nerve Stimulator?

The FDA product code for Transcutaneous Electrical Nerve Stimulator is GZJ.

Related Clinical Trials

NCT07517172 Evaluating Noninvasive Brain Stimulation for TMD Pain: A Feasibility Study RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT06816004 Noninvasive Vagal Nerve Stimulation ACTIVE_NOT_RECRUITING NCT07614945 Effect of Reflexology on Pain and Sleep Disorders in Females With Fibromyalgia NOT_YET_RECRUITING NCT06127550 taVNS for Letter Learning in Dyslexia SUSPENDED NCT07610655 Effects of Transcutaneous Vagal Nerve Stimulation on Post-Surgical Return to Consciousness, Delirium, and Depression RECRUITING

Other Devices by Wuxi Jiajian Medical Instrument Co., Ltd.

K202861Needle Stimulator K192568Jiajian Self-Adhesive Electrode K222879Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) K231425Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) K244030Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)

Related Devices (Code: GZJ)

K160246SimulCare II(TM)Xanacare Technologies, LLC K153704StriveDjo, LLC K152676FD TENS 2090, FD TENS 2095Fuji Dynamics , Ltd. K173233ReliefBand 1.5Reliefband Technologies K161091STIMPOD NMS460 Nerve StimulatorXavant Technology (Pty), Ltd. K162663WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605AWell-Life Healthcare Limited

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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