Cleared Traditional

K043326 - BEWELL

K043326 is an FDA 510(k) clearance for BEWELL, manufactured by Cycling and Health Tech. Industry R&D Center. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K043326 · Cycling and Health Tech. Industry R&D Center · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
55d
Days
Class 2
Risk

K043326 is an FDA 510(k) clearance for the BEWELL, MODEL SC 20. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Cycling and Health Tech. Industry R&D Center (Taichung, TW). The FDA issued a Cleared decision on January 26, 2005 after a review of 55 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.

View all Cycling and Health Tech. Industry R&D Center devices

FDA 510(k) Submission Details - K043326

510(k) Number K043326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2004
Decision Date January 26, 2005
Days to Decision 55 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
60d faster than avg
Panel avg: 115d · This submission: 55d
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 117
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K043326.
HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, P17RT
K070493 · Heartway Medical Products Co., Ltd. · Mar 2007
WU'S 3-WHEELED NEO SCOOTER, MODEL WT-T3E
K062790 · Wu'S Tech Co., Ltd. · Oct 2006
WU'S 4-WHEELED NEO SCOOTER, WT-XL4
K050042 · Wu'S Tech Co., Ltd. · Mar 2005
MEDLINE STRIDER MIDI 4
K042764 · Medline Industries, Inc. · Oct 2004
MODIFICATION TO MEDLINE STRIDER MIDI 3
K042763 · Medline Industries, Inc. · Oct 2004
MEDLINE STRIDER MICRO 3
K041053 · Medline Industries, Inc. · May 2004