The following data is part of a premarket notification filed by Kaye Products, Inc. with the FDA for Wheelchair, Mechanical.
| Device ID | K885330 |
| 510k Number | K885330 |
| Device Name: | WHEELCHAIR, MECHANICAL |
| Classification | Wheelchair, Mechanical |
| Applicant | KAYE PRODUCTS, INC. 1010 EAST PETTIGREW ST. Durham, NC 27701 |
| Contact | Edward S Howle |
| Correspondent | Edward S Howle KAYE PRODUCTS, INC. 1010 EAST PETTIGREW ST. Durham, NC 27701 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-28 |
| Decision Date | 1989-02-03 |