The following data is part of a premarket notification filed by Orthofab, Inc. with the FDA for Orthofab Wheelchair Astra (folding Manual Wheelchair).
| Device ID | K950904 |
| 510k Number | K950904 |
| Device Name: | ORTHOFAB WHEELCHAIR ASTRA (FOLDING MANUAL WHEELCHAIR) |
| Classification | Wheelchair, Mechanical |
| Applicant | ORTHOFAB, INC. 2160 DE CELLES Quebec City (quebec), CA G2c 1x8 |
| Contact | Claude Arcand |
| Correspondent | Claude Arcand ORTHOFAB, INC. 2160 DE CELLES Quebec City (quebec), CA G2c 1x8 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-28 |
| Decision Date | 1995-04-05 |