The following data is part of a premarket notification filed by Rehabtronics Inc. with the FDA for Prelivia.
| Device ID | K210979 |
| 510k Number | K210979 |
| Device Name: | Prelivia |
| Classification | Stimulator, Muscle, Powered |
| Applicant | Rehabtronics Inc. #4352, 10230 Jasper Avenue Edmonton, CA T5j 4p6 |
| Contact | Mike Pearson |
| Correspondent | Mike Pearson Rehabtronics Inc. #4352, 10230 Jasper Avenue Edmonton, CA T5j 4p6 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-01 |
| Decision Date | 2021-05-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17540176050022 | K210979 | 000 |
| 17540176050008 | K210979 | 000 |
| 17540176050046 | K210979 | 000 |
| 17540176050039 | K210979 | 000 |
| 17540176050114 | K210979 | 000 |
| 17540176050107 | K210979 | 000 |
| 17540176050091 | K210979 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PRELIVIA 79314983 not registered Live/Pending |
Rehabtronics Inc. 2021-04-09 |