The following data is part of a premarket notification filed by Intl. Medical Equipment Corp. with the FDA for Oc3 Flyer.
| Device ID | K832745 |
| 510k Number | K832745 |
| Device Name: | OC3 FLYER |
| Classification | Wheelchair, Powered |
| Applicant | INTL. MEDICAL EQUIPMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-15 |
| Decision Date | 1983-09-20 |