The following data is part of a premarket notification filed by Playmakar Inc. with the FDA for Playmakar Sport Muscle Stimulator, Model Pro-500.
| Device ID | K182581 |
| 510k Number | K182581 |
| Device Name: | PlayMakar Sport Muscle Stimulator, Model PRO-500 |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | PlayMakar Inc. 1603 Hart Street Southlake, TX 76092 |
| Contact | Mike Williams |
| Correspondent | Guenter Ginsberg Media Trade Corporation 11820 Red Hibiscus Drive Bonita Springs, FL 34135 |
| Product Code | NUH |
| Subsequent Product Code | NGX |
| Subsequent Product Code | NYN |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-19 |
| Decision Date | 2018-11-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856675008168 | K182581 | 000 |