Ceragem Automatic Thermal Massager (CGM MB-2401)— 510(k) K250266

Name: FDA 510(k) clearance K250266
Creator: U.S. Food and Drug Administration
Published: 2025-07-11

Substantially Equivalent

Ceragem Co., Ltd.

FDA 510(k) clearance K250266 for Ceragem Automatic Thermal Massager (CGM MB-2401), Substantially Equivalent on 2025-07-11. Applicant: Ceragem Co., Ltd.. Device class: 2.

Clearance details

Applicant: Ceragem Co., Ltd.
Product code: Code JFB
Device class: Class 2
Regulation: 21 CFR 890.5880
Advisory panel: Physical Medicine
Date received: 2025-01-30
Decision date: 2025-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cheonan-Si, KR

Download summary PDF View on FDA.gov ↗

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K202113 — Ceragem Automatic Thermal Massager, Model CGM-MB-19012021-03-02
K040031 — CERAGEM-C THERMAL ACUPRESSURE MASSAGER2004-07-28

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