CERAGEM AUTOMATIC THERMAL MASSAGER— 510(k) K140592

Name: FDA 510(k) clearance K140592
Creator: U.S. Food and Drug Administration
Published: 2014-12-17

Substantially Equivalent

Ceragem International, Inc.

FDA 510(k) clearance K140592 for CERAGEM AUTOMATIC THERMAL MASSAGER, Substantially Equivalent on 2014-12-17. Applicant: Ceragem International, Inc.. Device class: 2.

Clearance details

Applicant: Ceragem International, Inc.
Product code: Code JFB
Device class: Class 2
Regulation: 21 CFR 890.5880
Advisory panel: Physical Medicine
Date received: 2014-03-07
Decision date: 2014-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crofton, MD, US

Download summary PDF View on FDA.gov ↗

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