The following data is part of a premarket notification filed by Amylior, Inc. with the FDA for Amypower All Track Series Power Wheelchair.
| Device ID | K092225 |
| 510k Number | K092225 |
| Device Name: | AMYPOWER ALL TRACK SERIES POWER WHEELCHAIR |
| Classification | Wheelchair, Powered |
| Applicant | AMYLIOR, INC. 1650 CHICOINE VAUDREUIL- DORIAN Quebec, CA J7v 8p2 |
| Contact | Eric Dugas |
| Correspondent | Eric Dugas AMYLIOR, INC. 1650 CHICOINE VAUDREUIL- DORIAN Quebec, CA J7v 8p2 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-23 |
| Decision Date | 2009-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827482201752 | K092225 | 000 |
| 00827482201745 | K092225 | 000 |
| 00827482201738 | K092225 | 000 |
| 00827482201721 | K092225 | 000 |
| 00827482201714 | K092225 | 000 |