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FDA 510(k)

gel-e Flex+

K-Number: K182811 · 2019-08-29

ApplicantGel-E, Inc.
Decision Date2019-08-29
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

gel-e Flex+ is a medical device manufactured by Gel-E, Inc.. It received FDA 510(k) clearance on 2019-08-29 under approval number K182811. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the gel-e Flex+?

gel-e Flex+ is a medical device that received FDA 510(k) clearance on 2019-08-29. It is manufactured by Gel-E, Inc.. The 510(k) number is K182811.

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

gel-e Flex+ received FDA 510(k) clearance on 2019-08-29, under approval number K182811.

What company makes gel-e Flex+?

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

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

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

Other Devices by Gel-E, Inc.

K180152gel-e Flex K192667gel-e Flex+ gel OTC

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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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