Cleared Traditional

K955275 - BOOSTER TROPHY 5 MOTORIZED SCOOTER

K955275 is an FDA 510(k) clearance for BOOSTER TROPHY 5 MOTORIZED SCOOTER, manufactured by Optimed Technologies, Inc.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 355-day FDA review.

K955275 · Optimed Technologies, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
355d
Days
Class 2
Risk

K955275 is an FDA 510(k) clearance for the BOOSTER TROPHY 5 MOTORIZED SCOOTER. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Optimed Technologies, Inc. (Washington, US). The FDA issued a Cleared decision on November 4, 1996 after a review of 355 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3800 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Optimed Technologies, Inc. devices

FDA 510(k) Submission Details - K955275

510(k) Number K955275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
240d slower than avg
Panel avg: 115d · This submission: 355d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

INI Device Classification - Class 2, Special Controls

Product Code INI Vehicle, Motorized 3-wheeled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - INI Vehicle, Motorized 3-wheeled

All 91
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K955275.
INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3
K030814 · Invacare Corp. · Mar 2003
MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P, LYNX LX-3, LYNX LX-3, PANTHER LX-4
K010135 · Invacare Corp. · Feb 2001
MODELS LYNX AND PANTHER MOTORIZED SCOOTERS
K992052 · Invacare Corp. · Aug 1999
FORTRESS 1704FS FOUR WHEEL SCOOTER
K922966 · Fortress Scientific , Ltd. · Aug 1992
FORTRESS 1700FS REAR WHEEL DRIVE SCOOTER
K922967 · Fortress Scientific , Ltd. · Aug 1992
FORTRESS 1800FS REAR WHEEL DRIVE SCOOTER
K921069 · Fortress Scientific , Ltd. · Apr 1992