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 |