The following data is part of a premarket notification filed by Naico Corp. with the FDA for Naico Wheel Chairs.
| Device ID | K923291 |
| 510k Number | K923291 |
| Device Name: | NAICO WHEEL CHAIRS |
| Classification | Wheelchair, Mechanical |
| Applicant | NAICO CORP. 5868 W. 71ST ST. Indianapolis, IN 46278 |
| Contact | Tona L Hwang |
| Correspondent | Tona L Hwang NAICO CORP. 5868 W. 71ST ST. Indianapolis, IN 46278 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-06 |
| Decision Date | 1992-08-06 |