The following data is part of a premarket notification filed by Fig, Llc with the FDA for Powerplay Muscle Massager.
| Device ID | K122154 |
| 510k Number | K122154 |
| Device Name: | POWERPLAY MUSCLE MASSAGER |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | FIG, LLC 2839 HARVEST MOON DRIVE Orange Park, FL 32073 |
| Contact | Joe Adkins |
| Correspondent | Joe Adkins FIG, LLC 2839 HARVEST MOON DRIVE Orange Park, FL 32073 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-20 |
| Decision Date | 2012-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042809586022 | K122154 | 000 |
| 04042809585704 | K122154 | 000 |
| 04042809585711 | K122154 | 000 |
| 04042809585742 | K122154 | 000 |
| 04042809585759 | K122154 | 000 |
| 04042809585766 | K122154 | 000 |
| 04042809585773 | K122154 | 000 |
| 04042809585889 | K122154 | 000 |
| 04042809585896 | K122154 | 000 |
| 04042809585926 | K122154 | 000 |
| 04042809585698 | K122154 | 000 |