Cleared Traditional

K091482 - HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4

K091482 is an FDA 510(k) clearance for HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4, manufactured by Danyang Huayi Medical Supply & Equipment Co, Ltd.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K091482 · Danyang Huayi Medical Supply & Equipment Co, Ltd. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
48d
Days
Class 1
Risk

K091482 is an FDA 510(k) clearance for the HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Danyang Huayi Medical Supply & Equipment Co, Ltd. (Decatur, US). The FDA issued a Cleared decision on July 6, 2009 after a review of 48 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.

FDA 510(k) Submission Details - K091482

510(k) Number K091482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2009
Decision Date July 06, 2009
Days to Decision 48 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
68d faster than avg
Panel avg: 116d · This submission: 48d
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 441
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K091482.
MECHANICAL WHEELCHAIR, MODEL DS 202-S
K100824 · Suzhou KD Medical · May 2010
MULTI FRAME WHEELCHAIR
K100084 · R82 A/S · Apr 2010
18 STANDARD WHEELCHAIR, MODEL MS005-4, 18 RECLINING WHEELCHAIR , MODEL MS008-1, 14 PEDIATRIC WHEELCHAIR
K094047 · Modern Rehabilitation Solutions Co., Ltd. · Mar 2010
TREVAIR CHAIR
K091478 · Patmont Motor Werks, Inc. · Jun 2009
MARVEL PEDIATRIC WHEELCHAIR
K083847 · Rogue Wheelchairs, Inc. · Jan 2009
PANTHERA MECHANICAL WHEELCHAIR, MODELS S2, U2, BAMBINO, MICRO, BT
K083231 · Panthera Production AB · Jan 2009
K091482 · HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4
Download PDF FDA Summary Danyang Huayi Medical…