The following data is part of a premarket notification filed by Orthofab, Inc. with the FDA for Karma-rs, Karma-fs Wheelchairs.
| Device ID | K884812 |
| 510k Number | K884812 |
| Device Name: | KARMA-RS, KARMA-FS WHEELCHAIRS |
| Classification | Wheelchair, Powered |
| Applicant | ORTHOFAB, INC. 500 RUE DESROCHERS VANIER, QUEBEC Canada, Gim 1c2, CA |
| Contact | Jean-yves Cote |
| Correspondent | Jean-yves Cote ORTHOFAB, INC. 500 RUE DESROCHERS VANIER, QUEBEC Canada, Gim 1c2, CA |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-17 |
| Decision Date | 1988-12-27 |