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FDA 510(k)

AXUS ES-5 Electro-Acupuncture Device

K-Number: K200636 · 2021-02-03

ApplicantLhasa Oms, Inc.
Decision Date2021-02-03
Product CodeBWK
DecisionSubstantially Equivalent

Device Summary

AXUS ES-5 Electro-Acupuncture Device is a medical device manufactured by Lhasa Oms, Inc.. It received FDA 510(k) clearance on 2021-02-03 under approval number K200636. The device is classified under product code BWK. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXUS ES-5 Electro-Acupuncture Device?

AXUS ES-5 Electro-Acupuncture Device is a medical device that received FDA 510(k) clearance on 2021-02-03. It is manufactured by Lhasa Oms, Inc.. The 510(k) number is K200636.

When was AXUS ES-5 Electro-Acupuncture Device approved by the FDA?

AXUS ES-5 Electro-Acupuncture Device received FDA 510(k) clearance on 2021-02-03, under approval number K200636.

What company makes AXUS ES-5 Electro-Acupuncture Device?

AXUS ES-5 Electro-Acupuncture Device is manufactured by Lhasa Oms, Inc..

What is the FDA product code for AXUS ES-5 Electro-Acupuncture Device?

The FDA product code for AXUS ES-5 Electro-Acupuncture Device is BWK.

Related Clinical Trials

NCT05989217 Conservative Therapies in the Treatment of Temporomandibular Disorders COMPLETED NCT06219707 Electro-acupuncture for Irritable Bowel Syndrome With Constipation COMPLETED NCT07575750 Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Aromatase Inhibitor-induced Arthralgia (AIA) NOT_YET_RECRUITING NCT06491017 Effects of Mechanical Insufflation-Exsufflation With Optimized Settings on Wet Mucus Volume During Invasive Ventilation RECRUITING NCT07455409 Trial to Study Electro-Acupuncture in Subjects With Chemotherapy-Induced Peripheral Neuropathy COMPLETED NCT07538310 Laser Acupuncture for Fatigue in Hemodialysis Patients NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025)

Related Devices (Code: BWK)

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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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