EdgeFlow Gel Pad— 510(k) K252337

Substantially Equivalent

Edgecare, Inc.

FDA 510(k) clearance K252337 for EdgeFlow Gel Pad, Substantially Equivalent on 2026-04-24. Applicant: Edgecare, Inc..

Clearance details

Applicant: Edgecare, Inc.
Product code: Code MUI
Advisory panel: Radiology
Date received: 2025-07-28
Decision date: 2026-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

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