Cleared Abbreviated

K021371 - SUNSPEX TECHNOLOGIES MODEL SE 02

K021371 is an FDA 510(k) clearance for SUNSPEX TECHNOLOGIES MODEL SE 02, manufactured by Sunpex Technology Co., Ltd.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Abbreviated 510(k) pathway after a 16-day FDA review.

K021371 · Sunpex Technology Co., Ltd. · Physical Medicine device
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May 2002
Decision
16d
Days
Class 2
Risk

K021371 is an FDA 510(k) clearance for the SUNSPEX TECHNOLOGIES MODEL SE 02. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Sunpex Technology Co., Ltd. (Chia Yi City, TW). The FDA issued a Cleared decision on May 16, 2002 after a review of 16 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Sunpex Technology Co., Ltd. devices

FDA 510(k) Submission Details - K021371

510(k) Number K021371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2002
Decision Date May 16, 2002
Days to Decision 16 days
Submission Type Abbreviated
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 115d · This submission: 16d
Pathway characteristics
Standards-based clearance path.

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 191
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