Cleared Traditional

K181344 - C.T.M Mobility Scooter

K181344 is the FDA 510(k) clearance for C.T.M Mobility Scooter by Chien TI Enterprise Co., Ltd.. It is a Class 2 Physical Medicine device (product code INI) cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K181344 · Chien TI Enterprise Co., Ltd. · Physical Medicine device
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Dec 2018
Decision
207d
Days
Class 2
Risk

K181344 is an FDA 510(k) clearance for the C.T.M Mobility Scooter. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Chien TI Enterprise Co., Ltd. (New Taipei City, Hsin Chuang District, CN). The FDA issued a Cleared decision on December 14, 2018 after a review of 207 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 Chien TI Enterprise Co., Ltd. devices

Submission Details

510(k) Number K181344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2018
Decision Date December 14, 2018
Days to Decision 207 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
92d slower than avg
Panel avg: 115d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 79
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K181344.
SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)
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Solax Electric Scooter, Models: S302121, S302131, S302141, S302151
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Lite
K172409 · Tzora Active Systems , Ltd. · May 2018
HEARTWAY Power Mobility Scooter
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