The following data is part of a premarket notification filed by Optimed Technologies, Inc. with the FDA for Booster Lite 3 Motorized Scooter.
Device ID | K955274 |
510k Number | K955274 |
Device Name: | BOOSTER LITE 3 MOTORIZED SCOOTER |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | OPTIMED TECHNOLOGIES, INC. 300 K STREET, N.W. SUITE 500 Washington, DC 20007 |
Contact | Ilene G Otts |
Correspondent | Ilene G Otts 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 |