BODYHEAT

System, Thermal Regulating

MEDADVANCES, INC.

The following data is part of a premarket notification filed by Medadvances, Inc. with the FDA for Bodyheat.

Pre-market Notification Details

• Device ID: K902650
• 510k Number: K902650
• Device Name: BODYHEAT
• Classification: System, Thermal Regulating
• Applicant: MEDADVANCES, INC. 3414 22ND. ST. Lubbock, TX 79410
• Contact: Patrick J Griffin
• Correspondent: Patrick J Griffin; MEDADVANCES, INC. 3414 22ND. ST. Lubbock, TX 79410
• Product Code: DWJ
• CFR Regulation Number: 870.5900 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-06-15
• Decision Date: 1990-12-20