Cleared Traditional

K011473 - SNAZZY2

K011473 is an FDA 510(k) clearance for SNAZZY2, manufactured by Shoprider Intl., Inc.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K011473 · Shoprider Intl., Inc. · Physical Medicine device
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Nov 2001
Decision
186d
Days
Class 2
Risk

K011473 is an FDA 510(k) clearance for the SNAZZY2. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Shoprider Intl., Inc. (Hsiang, Hsinchu County, TW). The FDA issued a Cleared decision on November 16, 2001 after a review of 186 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.

FDA 510(k) Submission Details - K011473

510(k) Number K011473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2001
Decision Date November 16, 2001
Days to Decision 186 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
70d slower than avg
Panel avg: 116d · This submission: 186d
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 354
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K011473.
MINI SHOPPER
K013927 · Shoprider Intl., Inc. · Jan 2002
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5
K013788 · Merits Health Products Co., Ltd. · Dec 2001
COMPANION MODEL 221, 321, 421
K012258 · Golden Technologies, Inc. · Dec 2001
SOVEREIGN
K011476 · Shoprider Intl., Inc. · Oct 2001
C.T.M. MOBILITY SCOOTER MODEL # HS-320
K012791 · Warepalmy Enterprise, LLC (Usa) · Oct 2001
C.T.M. MOBITIY SCOOTER MODEL #HS-360
K012792 · Warepalmy Enterprise, LLC (Usa) · Oct 2001
K011473 · SNAZZY2
Download PDF Shoprider Intl., Inc.