Cleared Traditional

K022369 - COMFORT WINDJOY SCOOTER, MODEL LY-EW302

K022369 is an FDA 510(k) clearance for COMFORT WINDJOY SCOOTER, manufactured by Comfort Orthopedic Co., Ltd.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K022369 · Comfort Orthopedic Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
81d
Days
Class 2
Risk

K022369 is an FDA 510(k) clearance for the COMFORT WINDJOY SCOOTER, MODEL LY-EW302. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Comfort Orthopedic Co., Ltd. (Hsin-Chu City, TW). The FDA issued a Cleared decision on October 11, 2002 after a review of 81 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 - K022369

510(k) Number K022369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2002
Decision Date October 11, 2002
Days to Decision 81 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
35d faster than avg
Panel avg: 116d · This submission: 81d
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 K022369.
COMFORT AGILE SCOOTER, LY-EW303
K023581 · Comfort Orthopedic Co., Ltd. · Dec 2002
SUNPEX TECHNOLOGIES MODEL SE 01
K021925 · Sunpex Technology Co., Ltd. · Nov 2002
COMFORT DREAMRIDER SCOOTER, LY-EW402
K021910 · Comfort Orthopedic Co., Ltd. · Oct 2002
WU'S 4-WHEELED NEO SCOOTER, WT-L4
K013763 · Wu'S Tech Co., Ltd. · Jul 2002
WU'S 3-WHEELED NEO SCOOTER, WT-M3
K014119 · Wu'S Tech Co., Ltd. · Jul 2002
SUNSPEX TECHNOLOGIES MODEL SE 02
K021371 · Sunpex Technology Co., Ltd. · May 2002
K022369 · COMFORT WINDJOY SCOOTER, MODEL LY-EW302
Download PDF FDA Summary Comfort Orthopedic Co…