Cleared Traditional

K032919 - C.T.M. MOBILITY SCOOTER, MODEL HS-250

K032919 is an FDA 510(k) clearance for C.T.M. MOBILITY SCOOTER, manufactured by C.T.M. Homecare Product, Inc.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K032919 · C.T.M. Homecare Product, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
23d
Days
Class 2
Risk

K032919 is an FDA 510(k) clearance for the C.T.M. MOBILITY SCOOTER, MODEL HS-250. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by C.T.M. Homecare Product, Inc. (Phoenix, US). The FDA issued a Cleared decision on October 15, 2003 after a review of 23 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K032919

510(k) Number K032919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2003
Decision Date October 15, 2003
Days to Decision 23 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
93d faster than avg
Panel avg: 116d · This submission: 23d
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 334
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K032919.
BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500
K033239 · Tung Keng Enterprise Co., Ltd. · Nov 2003
WU'S 3-WHEELED NEO SCOOTER, MODEL WT-M3JR
K033032 · Wu'S Tech Co., Ltd. · Nov 2003
BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S320
K033241 · Tung Keng Enterprise Co., Ltd. · Nov 2003
COACH 777-3
K030756 · Wheelchair & Scooter Express · Oct 2003
COACH 777-4
K030757 · Wheelchair & Scooter Express · Oct 2003
C.T.M. MOBILITY SCOOTER, MODEL HS-235
K032918 · C.T.M. Homecare Product, Inc. · Oct 2003
K032919 · C.T.M. MOBILITY SCOOTER, MODEL HS-250
Download PDF FDA Summary C.T.M. Homecare Produ…