The following data is part of a premarket notification filed by Motion Composites with the FDA for Helio A7 Manual Wheelchair, Move Manual Wheelchair.
| Device ID | K143101 |
| 510k Number | K143101 |
| Device Name: | Helio A7 Manual Wheelchair, Move Manual Wheelchair |
| Classification | Wheelchair, Mechanical |
| Applicant | MOTION COMPOSITES 519 J-OSWALD-FOREST SUITE 101 Saint-roch-de-l' Achigan, CA J0k 3h0 |
| Contact | Vincent Leuyer |
| Correspondent | Edward A. Kroll Spectre Solutions, Inc. 5905 Fawn Lane Cleveland, OH 44141 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-29 |
| Decision Date | 2015-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811774000062 | K143101 | 000 |
| 00811774000017 | K143101 | 000 |