The following data is part of a premarket notification filed by Burke Mobility Products with the FDA for Booster Motorized Three Wheeled Vehicle.
| Device ID | K900738 |
| 510k Number | K900738 |
| Device Name: | BOOSTER MOTORIZED THREE WHEELED VEHICLE |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | BURKE MOBILITY PRODUCTS 1800 MERRIAM LN. Kansas City, KS 66106 |
| Contact | Duwayne E Kramer |
| Correspondent | Duwayne E Kramer BURKE MOBILITY PRODUCTS 1800 MERRIAM LN. Kansas City, KS 66106 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-16 |
| Decision Date | 1990-02-22 |