The following data is part of a premarket notification filed by Cool Systems, Inc. (dba Game Ready) with the FDA for Game Ready Grpro 2.1 System.
| Device ID | K192114 |
| 510k Number | K192114 |
| Device Name: | Game Ready GRPro 2.1 System |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | Cool Systems, Inc. (dba Game Ready) 1800 Sutter Street, Suite 500 Concord, CA 94520 |
| Contact | Natalie Kennel |
| Correspondent | Natalie Kennel NJK & Associates 13721 Via Tres Vista San Diego, CA 92129 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-06 |
| Decision Date | 2019-10-29 |
| Summary: | summary |