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 a medical device manufactured by Well Brain International , Ltd.. It received FDA 510(k) clearance on 2021-01-15 under approval 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. It is manufactured by Well Brain International , Ltd.. The 510(k) number is K202653.
When was Gymform Total ABS approved by the FDA?
Gymform Total ABS received FDA 510(k) clearance on 2021-01-15, under approval number K202653.
What company makes Gymform Total ABS?
Gymform Total ABS is manufactured by Well Brain International , Ltd..
What is the FDA product code for Gymform Total ABS?
The FDA product code for Gymform Total ABS is NGX.
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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.