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FDA 510(k)

Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)

K-Number: K220578 · 2022-05-25

ApplicantBozhou Rongjian Medical Appliance Co., Ltd.
Decision Date2022-05-25
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) is a medical device manufactured by Bozhou Rongjian Medical Appliance Co., Ltd.. It received FDA 510(k) clearance on 2022-05-25 under approval number K220578. 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 (Model RJTENS-1)?

Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) is a medical device that received FDA 510(k) clearance on 2022-05-25. It is manufactured by Bozhou Rongjian Medical Appliance Co., Ltd.. The 510(k) number is K220578.

When was Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) approved by the FDA?

Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) received FDA 510(k) clearance on 2022-05-25, under approval number K220578.

What company makes Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)?

Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) is manufactured by Bozhou Rongjian Medical Appliance Co., Ltd..

What is the FDA product code for Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)?

The FDA product code for Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) 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

Related PubMed Literature

PMID: 31472187 A translational framework for peripheral nerve stimulating electrodes: Reviewing the journey from concept to clinic. Journal of neuroscience methods (2019)

Other Devices by Bozhou Rongjian Medical Appliance Co., Ltd.

K220153Needle Stimulator (Model: RJNS6-1) K213879Self-adhesive Electrode K252688Transcutaneous Electrical Nerve Stimulator (RJTENS-2)

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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