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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 116d · 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 351
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K000354.
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER
K003815 · Merits Health Products., Inc. · Dec 2000
ELECTRIC MOBILITY RASCAL AND CHAUFFER SCOOTERS
K002616 · Electric Mobility Corp. · Dec 2000
IRV2000 INDIVIDUAL RECREATIONAL VEHICLE
K001835 · Trac About, Inc. · Oct 2000
C.T.M. MOBILITY SCOOTER, MODEL H2-686, HS-740, HS-580
K000356 · Warepalmy Enterprise, LLC (Usa) · Aug 2000
LA PERSONAL SCOOTER
K000869 · Assembled Products Corp. · Jul 2000
TMC-EASY-302
K984565 · Tmc Magnetics & Machinery Corp. · Feb 2000
K000354 · C.T.M. MOBILITY SCOOTERS HS-666, HS-730, HS-570
Download PDF FDA Summary Warepalmy Enterprise,…