The following data is part of a premarket notification filed by Fist Assist Devices, Llc with the FDA for Fist Assist Devices Model Fa-1.
| Device ID | K210281 |
| 510k Number | K210281 |
| Device Name: | Fist Assist Devices Model FA-1 |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | Fist Assist Devices, LLC 25599 Fernhill Road Los Altos, CA 94024 |
| Contact | Tej Singh |
| Correspondent | Tej Singh Fist Assist Devices, LLC 25599 Fernhill Road Los Altos, CA 94024 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-01 |
| Decision Date | 2021-06-17 |