Cleared Traditional

K043332 - WHEELCHAIR, MODEL 8500-II

K043332 is an FDA 510(k) clearance for WHEELCHAIR, manufactured by Cycling and Health Tech. Industry R&D Center. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K043332 · Cycling and Health Tech. Industry R&D Center · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
11d
Days
Class 1
Risk

K043332 is an FDA 510(k) clearance for the WHEELCHAIR, MODEL 8500-II. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Cycling and Health Tech. Industry R&D Center (Taichung, TW). The FDA issued a Cleared decision on December 13, 2004 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3850 - 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 - K043332

510(k) Number K043332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2004
Decision Date December 13, 2004
Days to Decision 11 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
105d faster than avg
Panel avg: 116d · This submission: 11d
Pathway characteristics
Predicate-based equivalence.

IOR Device Classification - Class 1, General Controls

Product Code IOR Wheelchair, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3850
Definition A Mechanical Wheelchair Is A Manually Operated Device With Wheels That Is Intended For Medical Purposes To Provide Mobility To Persons Restricted To A Sitting Position. Fda Interprets “mobility To Persons Restricted To A Sitting Position” To Mean The Device Type Is Intended To Provide Mobility To Individuals Who Have Mobility Impairments And/or Require An Assistive Device For Mobility.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IOR Wheelchair, Mechanical

All 332
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K043332.
TRANSPORT SERIES TRANSPORT CHAIR
K050281 · Access Point Medical, LLC · Apr 2005
CIE FOLDAWAY WHEELCHAIR
K050345 · Carlsbad International Export, Inc. · Mar 2005
LERADO, COSCO
K050290 · Lerado Oversea Ltd. Twn Branch (Bvi) · Feb 2005
TAIWAN KING STRONG TC 04 MECHANICALWHEELCHAIR
K042652 · Taiwan King Strong Co., Ltd. · Nov 2004
LITESTREAM 500E
K042444 · Pride Mobility Products Corp. · Oct 2004
VARI-ABLE APB (ADAPTABLE POSITIONING BASE)
K042401 · American Track Roadsters, Inc. · Oct 2004