Device Classification Name |
massager, powered inflatable tube
|
510(k) Number |
K192114 |
Device Name |
Game Ready GRPro 2.1 System |
Applicant |
Cool Systems, Inc. (dba Game Ready) |
1800 Sutter Street, Suite 500 |
Concord,
CA
94520
|
|
Applicant Contact |
Natalie Kennel |
Correspondent |
NJK & Associates |
13721 Via Tres Vista |
San Diego,
CA
92129
|
|
Correspondent Contact |
Natalie Kennel |
Regulation Number | 890.5650
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/06/2019 |
Decision Date | 10/29/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|