Cleared Traditional

K022698 - SCOOTER MARS SERIES, MODEL TL-588

K022698 is an FDA 510(k) clearance for SCOOTER MARS SERIES, manufactured by Teh Lin Prosthetic & Orthopaedic, Inc.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K022698 · Teh Lin Prosthetic & Orthopaedic, Inc. · Physical Medicine device
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Dec 2002
Decision
111d
Days
Class 2
Risk

K022698 is an FDA 510(k) clearance for the SCOOTER MARS SERIES, MODEL TL-588. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Teh Lin Prosthetic & Orthopaedic, Inc. (Hsin Chu City, TW). The FDA issued a Cleared decision on December 2, 2002 after a review of 111 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 - K022698

510(k) Number K022698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2002
Decision Date December 02, 2002
Days to Decision 111 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
5d faster than avg
Panel avg: 116d · This submission: 111d
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 K022698.
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K021910 · Comfort Orthopedic Co., Ltd. · Oct 2002
K022698 · SCOOTER MARS SERIES, MODEL TL-588
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