Cleared Traditional

K000354 - C.T.M. MOBILITY SCOOTERS HS-666, HS-730, HS-570

K000354 is an FDA 510(k) clearance for C.T.M. MOBILITY SCOOTERS HS-666, manufactured by Warepalmy Enterprise, LLC (Usa). The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K000354 · Warepalmy Enterprise, LLC (Usa) · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
203d
Days
Class 2
Risk

K000354 is an FDA 510(k) clearance for the C.T.M. MOBILITY SCOOTERS HS-666, HS-730, HS-570. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Warepalmy Enterprise, LLC (Usa) (Phoenix, US). The FDA issued a Cleared decision on August 25, 2000 after a review of 203 days - an extended review cycle.

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. Standard predicate reliance. 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 Warepalmy Enterprise, LLC (Usa) devices

FDA 510(k) Submission Details - K000354

510(k) Number K000354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2000
Decision Date August 25, 2000
Days to Decision 203 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 115d · This submission: 203d
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 174
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K000354.
LASER 3 SPSC300
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LASER 4SPSC340
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MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P, LYNX LX-3, LYNX LX-3, PANTHER LX-4
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TMC-EASY-302
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GLORY
K994127 · Pillar Technology, Inc. · Feb 2000
ELECTRIC MOBILITY CAVALIER SCOOTERS
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