GAME READY CLASSIC SYSTEM, MODEL 550550

Massager, Powered Inflatable Tube

COOLSYSTEMS, INC.

The following data is part of a premarket notification filed by Coolsystems, Inc. with the FDA for Game Ready Classic System, Model 550550.

Pre-market Notification Details

• Device ID: K072620
• 510k Number: K072620
• Device Name: GAME READY CLASSIC SYSTEM, MODEL 550550
• Classification: Massager, Powered Inflatable Tube
• Applicant: COOLSYSTEMS, INC. 2201 DWIGHT WAY Berkeley, CA 94704
• Contact: Marianne Baldwin
• Correspondent: Marianne Baldwin; COOLSYSTEMS, INC. 2201 DWIGHT WAY Berkeley, CA 94704
• Product Code: IRP
• CFR Regulation Number: 890.5650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-09-17
• Decision Date: 2007-10-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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