The following data is part of a premarket notification filed by Bruno Independent Living Aids, Inc. with the FDA for Regal Motorizied 3 Wheeled Vehicle.
| Device ID | K921647 |
| 510k Number | K921647 |
| Device Name: | REGAL MOTORIZIED 3 WHEELED VEHICLE |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | BRUNO INDEPENDENT LIVING AIDS, INC. 430 ARMOUR COURT Oconomowoc, WI 53066 |
| Contact | Belson Iii |
| Correspondent | Belson Iii BRUNO INDEPENDENT LIVING AIDS, INC. 430 ARMOUR COURT Oconomowoc, WI 53066 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-06 |
| Decision Date | 1992-05-04 |