Cleared Traditional

K031313 - TMC ELECTRICAL SCOOTER, EASY 405

K031313 is an FDA 510(k) clearance for TMC ELECTRICAL SCOOTER, manufactured by Tmc Technology Corp.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K031313 · Tmc Technology Corp. · Physical Medicine device
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Sep 2003
Decision
133d
Days
Class 2
Risk

K031313 is an FDA 510(k) clearance for the TMC ELECTRICAL SCOOTER, EASY 405. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Tmc Technology Corp. (Hsin-Chu City, TW). The FDA issued a Cleared decision on September 4, 2003 after a review of 133 days - within the typical 510(k) review window.

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 - K031313

510(k) Number K031313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2003
Decision Date September 04, 2003
Days to Decision 133 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 116d · This submission: 133d
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 K031313.
JUSTWIN SCOOTER, MODEL JS-401
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PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER
K031897 · Imc-Heart Way LLC · Sep 2003
TMC ELECTRICAL SCOOTER, EASY 411
K031314 · Tmc Technology Corp. · Sep 2003
TMC ELECTRICAL SCOOTER, EASY 321
K031315 · Tmc Technology Corp. · Sep 2003
COACH 888
K030758 · Wheelchair & Scooter Express · Jul 2003
K031313 · TMC ELECTRICAL SCOOTER, EASY 405
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