The following data is part of a premarket notification filed by Optimed Technologies, Inc. with the FDA for Booster Trophy 5 Motorized Scooter.
| Device ID | K955275 |
| 510k Number | K955275 |
| Device Name: | BOOSTER TROPHY 5 MOTORIZED SCOOTER |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | OPTIMED TECHNOLOGIES, INC. 300 K STREET, N.W. SUITE 500 Washington, DC 20007 |
| Contact | Ilene K Gotts |
| Correspondent | Ilene K Gotts OPTIMED TECHNOLOGIES, INC. 300 K STREET, N.W. SUITE 500 Washington, DC 20007 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-15 |
| Decision Date | 1996-11-04 |