CoolSystems Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014274845 | 3014274845 | CoolSystems Inc. | 1 | N | 2020-04-25 | 2170 Anntom Drive, Unit 7 Ft Lauderdale FL US 33312 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 216189 | 1023224601 | K072620 | GAME READY CLASSIC SYSTEM, MODEL 550550 | IRP | 2007-10-31 |
| 216189 | 1698177481 | K071050 | GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM | IRP | 2007-06-29 |
| 216189 | 2038225571 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| IRP | 2 | 2007-10-31 |