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FDA 510(k)

Gymform Total ABS

K-Number: K202653 · 2021-01-15

ApplicantWell Brain International , Ltd.
Decision Date2021-01-15
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Gymform Total ABS is the device name listed in this FDA 510(k) record. The listed applicant is Well Brain International , Ltd.. It received FDA 510(k) clearance on 2021-01-15 under 510(k) number K202653. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gymform Total ABS?

Gymform Total ABS is a medical device that received FDA 510(k) clearance on 2021-01-15. The listed applicant is Well Brain International , Ltd.. The 510(k) number is K202653.

When did Gymform Total ABS receive FDA 510(k) clearance?

Gymform Total ABS received FDA 510(k) clearance on 2021-01-15, under 510(k) number K202653.

Who is the listed applicant for Gymform Total ABS?

The FDA 510(k) record lists Well Brain International , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gymform Total ABS?

The FDA product code for Gymform Total ABS is NGX.

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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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