The following data is part of a premarket notification filed by Motion Composites with the FDA for Apex Manual Wheelchair.
| Device ID | K161425 |
| 510k Number | K161425 |
| Device Name: | APEX Manual Wheelchair |
| Classification | Wheelchair, Mechanical |
| Applicant | Motion Composites 519 J. Oswald Forest-suite 101 St-roch-de-l'achigan, CA J0k3h0 |
| Contact | Stephane Le Beau |
| Correspondent | Stephane Le Beau Motion Composites 519 J. Oswald Forest-suite 101 St-roch-de-l'achigan, CA J0k3h0 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-23 |
| Decision Date | 2016-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811774000086 | K161425 | 000 |
| 00811774000079 | K161425 | 000 |