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FDA 510(k)

AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)

K-Number: K222867 · 2022-12-21

ApplicantAndon Health Co, Ltd.
Decision Date2022-12-21
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) is a medical device manufactured by Andon Health Co, Ltd.. It received FDA 510(k) clearance on 2022-12-21 under approval number K222867. 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 AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)?

AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) is a medical device that received FDA 510(k) clearance on 2022-12-21. It is manufactured by Andon Health Co, Ltd.. The 510(k) number is K222867.

When was AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) approved by the FDA?

AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) received FDA 510(k) clearance on 2022-12-21, under approval number K222867.

What company makes AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)?

AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) is manufactured by Andon Health Co, Ltd..

What is the FDA product code for AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)?

The FDA product code for AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) 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

Related PubMed Literature

PMID: 40003250 Bridging the Gap in FDA Approval for Pediatric Neuromodulation Devices. Children (Basel, Switzerland) (2025)

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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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