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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 the device name listed in this FDA 510(k) record. The listed applicant is Lhasa Oms, Inc.. It received FDA 510(k) clearance on 2021-02-03 under 510(k) 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. The listed applicant is Lhasa Oms, Inc.. The 510(k) number is K200636.

When did AXUS ES-5 Electro-Acupuncture Device receive FDA 510(k) clearance?

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

Who is the listed applicant for AXUS ES-5 Electro-Acupuncture Device?

The FDA 510(k) record lists Lhasa Oms, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: BWK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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