Cleared Traditional

BOOSTER TROPHY 5 MOTORIZED SCOOTER

K955275 · Optimed Technologies, Inc. · Physical Medicine
Nov 1996
Decision
355d
Days
Class 2
Risk

About This 510(k) Submission

K955275 is an FDA 510(k) clearance for the BOOSTER TROPHY 5 MOTORIZED SCOOTER, a Vehicle, Motorized 3-wheeled (Class II — Special Controls, product code INI), submitted by Optimed Technologies, Inc. (Washington, US). The FDA issued a Cleared decision on November 4, 1996, 355 days after receiving the submission on November 15, 1995. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3800.

Submission Details

510(k) Number K955275 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 1995
Decision Date November 04, 1996
Days to Decision 355 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code INI — Vehicle, Motorized 3-wheeled
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.3800

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