The following data is part of a premarket notification filed by Alpha One with the FDA for Renegade Wheelchair.
| Device ID | K082857 |
| 510k Number | K082857 |
| Device Name: | RENEGADE WHEELCHAIR |
| Classification | Wheelchair, Special Grade |
| Applicant | ALPHA ONE 5600 WISCONSIN AVE SUITE 509 Chevy Chase, MD 20815 |
| Contact | Patsy J Trisler |
| Correspondent | Patsy J Trisler ALPHA ONE 5600 WISCONSIN AVE SUITE 509 Chevy Chase, MD 20815 |
| Product Code | IQC |
| CFR Regulation Number | 890.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-29 |
| Decision Date | 2009-01-06 |
| Summary: | summary |