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FDA 510(k)

Transcutaneous Electrical Nerve Stimulator (RJTENS-2)

K-Number: K252688 · 2025-11-24

ApplicantBozhou Rongjian Medical Appliance Co., Ltd.
Decision Date2025-11-24
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Transcutaneous Electrical Nerve Stimulator (RJTENS-2) is a medical device manufactured by Bozhou Rongjian Medical Appliance Co., Ltd.. It received FDA 510(k) clearance on 2025-11-24 under approval number K252688. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Transcutaneous Electrical Nerve Stimulator (RJTENS-2)?

Transcutaneous Electrical Nerve Stimulator (RJTENS-2) is a medical device that received FDA 510(k) clearance on 2025-11-24. It is manufactured by Bozhou Rongjian Medical Appliance Co., Ltd.. The 510(k) number is K252688.

When was Transcutaneous Electrical Nerve Stimulator (RJTENS-2) approved by the FDA?

Transcutaneous Electrical Nerve Stimulator (RJTENS-2) received FDA 510(k) clearance on 2025-11-24, under approval number K252688.

What company makes Transcutaneous Electrical Nerve Stimulator (RJTENS-2)?

Transcutaneous Electrical Nerve Stimulator (RJTENS-2) is manufactured by Bozhou Rongjian Medical Appliance Co., Ltd..

What is the FDA product code for Transcutaneous Electrical Nerve Stimulator (RJTENS-2)?

The FDA product code for Transcutaneous Electrical Nerve Stimulator (RJTENS-2) is NUH.

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 Bozhou Rongjian Medical Appliance Co., Ltd.

K220578Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) K220153Needle Stimulator (Model: RJNS6-1) K213879Self-adhesive Electrode

Related Devices (Code: NUH)

K162630CP Relief Wand-OTCMid-America Medical Innovations, LLC K161453WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605AWell-Life Healthcare Limited K160508Electronic Pulse StimulatorBeijing Choice Electronic Technololgy Co., Ltd. K161537OTC TENS Device, Model PTS-IVCounter Scientific Development (Gz), Ltd. K151995Painmaster MCT PatchNewmark, Inc. K160255HBOTC Muscle and Nerve StimulatorHb Medical, Inc.

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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