The following data is part of a premarket notification filed by Roughrider America Llc with the FDA for Roughrider Aurora Manual Wheelchair.
| Device ID | K200715 |
| 510k Number | K200715 |
| Device Name: | RoughRider Aurora Manual Wheelchair |
| Classification | Wheelchair, Mechanical |
| Applicant | RoughRider America LLC 2233 California Street Berkley, CA 94703 |
| Contact | Marc Krizack |
| Correspondent | Marc Krizack RoughRider America LLC 2233 California Street Berkley, CA 94703 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-18 |
| Decision Date | 2022-06-24 |