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FDA 510(k)

Flex Fit

K-Number: K190790 · 2020-07-31

ApplicantDk Mungyo Corporation
Decision Date2020-07-31
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Flex Fit is a medical device manufactured by Dk Mungyo Corporation. It received FDA 510(k) clearance on 2020-07-31 under approval number K190790. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Flex Fit?

Flex Fit is a medical device that received FDA 510(k) clearance on 2020-07-31. It is manufactured by Dk Mungyo Corporation. The 510(k) number is K190790.

When was Flex Fit approved by the FDA?

Flex Fit received FDA 510(k) clearance on 2020-07-31, under approval number K190790.

What company makes Flex Fit?

Flex Fit is manufactured by Dk Mungyo Corporation.

What is the FDA product code for Flex Fit?

The FDA product code for Flex Fit is EBI.

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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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