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FDA 510(k)

gel-e Flex+ gel OTC

K-Number: K192667 · 2019-10-25

ApplicantGel-E, Inc.
Decision Date2019-10-25
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

gel-e Flex+ gel OTC is a medical device manufactured by Gel-E, Inc.. It received FDA 510(k) clearance on 2019-10-25 under approval number K192667. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the gel-e Flex+ gel OTC?

gel-e Flex+ gel OTC is a medical device that received FDA 510(k) clearance on 2019-10-25. It is manufactured by Gel-E, Inc.. The 510(k) number is K192667.

When was gel-e Flex+ gel OTC approved by the FDA?

gel-e Flex+ gel OTC received FDA 510(k) clearance on 2019-10-25, under approval number K192667.

What company makes gel-e Flex+ gel OTC?

gel-e Flex+ gel OTC is manufactured by Gel-E, Inc..

What is the FDA product code for gel-e Flex+ gel OTC?

The FDA product code for gel-e Flex+ gel OTC is QSY.

Other Devices by Gel-E, Inc.

K180152gel-e Flex K182811gel-e Flex+

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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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