The following data is part of a premarket notification filed by Brookefield Hunter, Inc. with the FDA for Ultra R-11 Cruiser.
| Device ID | K915609 |
| 510k Number | K915609 |
| Device Name: | ULTRA R-11 CRUISER |
| Classification | Wheelchair, Powered |
| Applicant | BROOKEFIELD HUNTER, INC. 880 N. MAIN ST. Oregon, WI 53575 |
| Contact | Ron Erfurth |
| Correspondent | Ron Erfurth BROOKEFIELD HUNTER, INC. 880 N. MAIN ST. Oregon, WI 53575 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-05 |
| Decision Date | 1992-02-11 |