Cleared Traditional

K952042 - TRAVEL EASE ELECTRIC SCOOTER

K952042 is an FDA 510(k) clearance for TRAVEL EASE ELECTRIC SCOOTER, manufactured by Merits Health Products Co., Ltd.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 308-day FDA review.

K952042 · Merits Health Products Co., Ltd. · Physical Medicine device
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Mar 1996
Decision
308d
Days
Class 2
Risk

K952042 is an FDA 510(k) clearance for the TRAVEL EASE ELECTRIC SCOOTER, MODEL: PIONEER. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Merits Health Products Co., Ltd. (Cape Copral, US). The FDA issued a Cleared decision on March 4, 1996 after a review of 308 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 Merits Health Products Co., Ltd. devices

FDA 510(k) Submission Details - K952042

510(k) Number K952042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1995
Decision Date March 04, 1996
Days to Decision 308 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
193d slower than avg
Panel avg: 115d · This submission: 308d
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 117
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K952042.
WU'S 3-WHEELED NEO SCOOTER, WT-M3
K014119 · Wu'S Tech Co., Ltd. · Jul 2002
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