The following data is part of a premarket notification filed by Biomedical Horizons, Inc. with the FDA for Biomedical Horizons Model 1001.
| Device ID | K921369 |
| 510k Number | K921369 |
| Device Name: | BIOMEDICAL HORIZONS MODEL 1001 |
| Classification | Components, Wheelchair |
| Applicant | BIOMEDICAL HORIZONS, INC. P.O. BOX 889 Jackson, MI 49204 |
| Contact | William Donahue |
| Correspondent | William Donahue BIOMEDICAL HORIZONS, INC. P.O. BOX 889 Jackson, MI 49204 |
| Product Code | KNN |
| CFR Regulation Number | 890.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-20 |
| Decision Date | 1992-05-11 |