Device Classification Name |
stimulator, nerve, transcutaneous, over-the-counter
|
510(k) Number |
K182581 |
Device Name |
PlayMakar Sport Muscle Stimulator, Model PRO-500 |
Applicant |
PlayMakar Inc. |
1603 Hart Street |
Southlake,
TX
76092
|
|
Applicant Contact |
Mike Williams |
Correspondent |
Media Trade Corporation |
11820 Red Hibiscus Drive |
Bonita Springs,
FL
34135
|
|
Correspondent Contact |
Guenter Ginsberg |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/19/2018 |
Decision Date | 11/21/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|