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.. Device class: 2.

Clearance details

Applicant: Edgecare, Inc.
Product code: Code MUI
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 2025-07-28
Decision date: 2026-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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More clearances from Edgecare, Inc.

K252237 — EdgeFlow UW202026-04-17
K231677 — EdgeFlow UH102024-03-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.