The following data is part of a premarket notification filed by Arizona Freedom Wheels, Inc. with the FDA for Freedom Wheels Az 100.
| Device ID | K913901 |
| 510k Number | K913901 |
| Device Name: | FREEDOM WHEELS AZ 100 |
| Classification | Wheelchair, Powered |
| Applicant | ARIZONA FREEDOM WHEELS, INC. P.O. BOX 42585 Phoenix, AZ 85080 |
| Contact | John Wrzesinski |
| Correspondent | John Wrzesinski ARIZONA FREEDOM WHEELS, INC. P.O. BOX 42585 Phoenix, AZ 85080 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-30 |
| Decision Date | 1991-10-07 |