The following data is part of a premarket notification filed by Coolsystems, Inc. with the FDA for Game Ready Professional Therapy System, Model 550100, Game Ready Pre-programmed Professional Therapy System.
| Device ID | K071050 |
| 510k Number | K071050 |
| Device Name: | GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM |
| 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 | 2007-04-13 |
| Decision Date | 2007-06-29 |
| Summary: | summary |