Cleared Traditional

K052558 - VCS, MODEL S4T

K052558 is an FDA 510(k) clearance for VCS, manufactured by Cycling and Health Tech. Industry R&D Center/Chc. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K052558 · Cycling and Health Tech. Industry R&D Center/Chc · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
41d
Days
Class 2
Risk

K052558 is an FDA 510(k) clearance for the VCS, MODEL S4T. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Cycling and Health Tech. Industry R&D Center/Chc (Taichung, TW). The FDA issued a Cleared decision on October 27, 2005 after a review of 41 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/Chc devices

FDA 510(k) Submission Details - K052558

510(k) Number K052558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2005
Decision Date October 27, 2005
Days to Decision 41 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
75d faster than avg
Panel avg: 116d · This submission: 41d
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 310
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K052558.
THE ELITE - ULTRA-LIGHT, COMPACT PORTABLE SCOOTER
K052204 · Tzora Active Systems , Ltd. · Feb 2006
LANDLEX, MODEL P100X
K060042 · Besteam Technology, Inc. · Feb 2006
BREEZE
K051028 · Afikim Electric Vehicles · Jan 2006
KING I POWERED SCOOTER, MODEL CTL-11
K052673 · King I Tech Corporation · Oct 2005
PROASIA, MODEL L3402
K052378 · Proasia Limited · Oct 2005
PROASIA, MODEL L4501
K052486 · Proasia Limited · Oct 2005