The following data is part of a premarket notification filed by Poirier S.a. with the FDA for Union Wheelchair.
| Device ID | K840625 |
| 510k Number | K840625 |
| Device Name: | UNION WHEELCHAIR |
| Classification | Wheelchair, Special Grade |
| Applicant | POIRIER S.A. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IQC |
| CFR Regulation Number | 890.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-20 |
| Decision Date | 1984-02-27 |