Cleared Traditional

K181344 - C.T.M Mobility Scooter

K181344 is an FDA 510(k) clearance for C.T.M Mobility Scooter, manufactured by Chien TI Enterprise Co., Ltd.. The device is a Class 2 Physical Medicine device with 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

FDA 510(k) Submission Details - K181344

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.

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 240
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K181344.
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