The following data is part of a premarket notification filed by Orthofab, Inc. with the FDA for Powered Wheelchair.
| Device ID | K962565 |
| 510k Number | K962565 |
| Device Name: | POWERED WHEELCHAIR |
| Classification | Wheelchair, Powered |
| Applicant | ORTHOFAB, INC. 2160, RUE DE CELLES Quebec City, Quebec, CA G2c 1x8 |
| Contact | Richard Lapierre |
| Correspondent | Richard Lapierre ORTHOFAB, INC. 2160, RUE DE CELLES Quebec City, Quebec, CA G2c 1x8 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-01 |
| Decision Date | 1997-03-20 |