CERAGEM AUTOMATIC THERMAL MASSAGER

Table, Physical Therapy, Multi Function

CERAGEM INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Ceragem International, Inc. with the FDA for Ceragem Automatic Thermal Massager.

Pre-market Notification Details

• Device ID: K140592
• 510k Number: K140592
• Device Name: CERAGEM AUTOMATIC THERMAL MASSAGER
• Classification: Table, Physical Therapy, Multi Function
• Applicant: CERAGEM INTERNATIONAL, INC. 1468 Harwell Avenue Crofton, MD 21114
• Contact: E.j. Smith
• Correspondent: E.j. Smith; CERAGEM INTERNATIONAL, INC. 1468 Harwell Avenue Crofton, MD 21114
• Product Code: JFB
• CFR Regulation Number: 890.5880 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-03-07
• Decision Date: 2014-12-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08809494000006	K140592	000