Cleared Traditional

K122749 - PRESTIGE-MOBIE

K122749 is an FDA 510(k) clearance for PRESTIGE-MOBIE, manufactured by Prestige Sporting Goods Co. , Ltd.. 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.

K122749 · Prestige Sporting Goods Co. , Ltd. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
111d
Days
Class 2
Risk

K122749 is an FDA 510(k) clearance for the PRESTIGE-MOBIE. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Prestige Sporting Goods Co. , Ltd. (Taichung, TW). The FDA issued a Cleared decision on December 27, 2012 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 - K122749

510(k) Number K122749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2012
Decision Date December 27, 2012
Days to Decision 111 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
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 334
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K122749.
HEARTWAY POWER MOBILITY SCOOTER
K132855 · Heartway Medical Products Co., Ltd. · Aug 2014
SOLAX
K131302 · Dongguan Prestige Sporting Goods Co., Ltd. · Nov 2013
KYMCO EQ20C SCOOTER
K130940 · Kwang Yang Motor Co., Ltd. · Oct 2013
FREERIDER MODEL LUGGIE MODEL 168-4IT
K110165 · Freerider Luggie Scooters, Inc. · Sep 2011
LOTUS BLAKE ESTEEM SCOOTER
K103771 · Letrix Power Hangzhou Pty, Ltd. · May 2011
C.T.M. MOBILITY SCOOTER - MODEL HS 118
K110395 · C.T.M. Homecare Product, Inc. · Apr 2011
K122749 · PRESTIGE-MOBIE
Download PDF FDA Summary Prestige Sporting Goo…