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FDA 510(k)

Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122)

K-Number: K250784 · 2025-08-21

ApplicantShenzhen Yicai Health Technology Co., Ltd.
Decision Date2025-08-21
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122) is a medical device manufactured by Shenzhen Yicai Health Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-08-21 under approval number K250784. 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 ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122)?

Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122) is a medical device that received FDA 510(k) clearance on 2025-08-21. It is manufactured by Shenzhen Yicai Health Technology Co., Ltd.. The 510(k) number is K250784.

When was Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122) approved by the FDA?

Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122) received FDA 510(k) clearance on 2025-08-21, under approval number K250784.

What company makes Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122)?

Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122) is manufactured by Shenzhen Yicai Health Technology Co., Ltd..

What is the FDA product code for Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122)?

The FDA product code for Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122) 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 Shenzhen Yicai Health Technology Co., Ltd.

K241119Transcutaneous Electrical Nerve Stimulator (K6106) K251623Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)

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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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