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FDA 510(k)

EdgeFlow Gel Pad

K-Number: K252337 · 2026-04-24

ApplicantEdgecare, Inc.
Decision Date2026-04-24
Product CodeMUI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EdgeFlow Gel Pad is a medical device manufactured by Edgecare, Inc.. It received FDA 510(k) clearance on 2026-04-24 under approval number K252337. The device is classified under product code MUI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EdgeFlow Gel Pad?

EdgeFlow Gel Pad is a medical device that received FDA 510(k) clearance on 2026-04-24. It is manufactured by Edgecare, Inc.. The 510(k) number is K252337.

When was EdgeFlow Gel Pad approved by the FDA?

EdgeFlow Gel Pad received FDA 510(k) clearance on 2026-04-24, under approval number K252337.

What company makes EdgeFlow Gel Pad?

EdgeFlow Gel Pad is manufactured by Edgecare, Inc..

What is the FDA product code for EdgeFlow Gel Pad?

The FDA product code for EdgeFlow Gel Pad is MUI.

Other Devices by Edgecare, Inc.

K231677EdgeFlow UH10 K252237EdgeFlow UW20

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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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