Cleared Traditional

K102358 - ZIP'R3/ ZIP'R3 XTRA SCOOTER

K102358 is an FDA 510(k) clearance for ZIP'R3/ ZIP'R3 XTRA SCOOTER, manufactured by Global Fabtech Wheelchair (Shanghai) Co., Ltd.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K102358 · Global Fabtech Wheelchair (Shanghai) Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
46d
Days
Class 2
Risk

K102358 is an FDA 510(k) clearance for the ZIP'R3/ ZIP'R3 XTRA SCOOTER. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Global Fabtech Wheelchair (Shanghai) Co., Ltd. (Taichung, TW). The FDA issued a Cleared decision on October 4, 2010 after a review of 46 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K102358

510(k) Number K102358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2010
Decision Date October 04, 2010
Days to Decision 46 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 116d · This submission: 46d
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 333
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K102358.
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K102358 · ZIP'R3/ ZIP'R3 XTRA SCOOTER
Download PDF FDA Summary Global Fabtech Wheelc…