Cleared Traditional

K110395 - C.T.M. MOBILITY SCOOTER - MODEL HS 118

K110395 is an FDA 510(k) clearance for C.T.M. MOBILITY SCOOTER - MODEL HS 118, 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 70-day FDA review.

K110395 · 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
Apr 2011
Decision
70d
Days
Class 2
Risk

K110395 is an FDA 510(k) clearance for the C.T.M. MOBILITY SCOOTER - MODEL HS 118. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by C.T.M. Homecare Product, Inc. (Eugene, US). The FDA issued a Cleared decision on April 22, 2011 after a review of 70 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 - K110395

510(k) Number K110395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2011
Decision Date April 22, 2011
Days to Decision 70 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
46d faster than avg
Panel avg: 116d · This submission: 70d
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 333
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K110395 · C.T.M. MOBILITY SCOOTER - MODEL HS 118
Download PDF FDA Summary C.T.M. Homecare Produ…