Cleared Traditional

K080207 - DANYANG HUAYI K2 AND K7 WHEELCHAIRS

K080207 is an FDA 510(k) clearance for DANYANG HUAYI K2 AND K7 WHEELCHAIRS, 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 44-day FDA review.

K080207 · 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
Mar 2008
Decision
44d
Days
Class 1
Risk

K080207 is an FDA 510(k) clearance for the DANYANG HUAYI K2 AND K7 WHEELCHAIRS. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Danyang Huayi Medical Supply & Equipment Co, Ltd. (Potomac, US). The FDA issued a Cleared decision on March 12, 2008 after a review of 44 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 - K080207

510(k) Number K080207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2008
Decision Date March 12, 2008
Days to Decision 44 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
72d faster than avg
Panel avg: 116d · This submission: 44d
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 K080207.
MARTIN CHAIR, MODEL C4S1
K080506 · Martin Manufacturing Co., LLC · Jun 2008
MANUAL RIGID MOBILITY WHEELCHAIR
K080270 · Freedom Designs, Inc. · Apr 2008
RTM AND OVAL
K080880 · Next Mobility, LLC · Apr 2008
HUAYI H035 BASIC WHEELCHAIR
K080114 · Danyang Huayi Medical Supply & Equipment Co, Ltd. · Feb 2008
START JUNIOR
K073512 · Otto Bock Healthcare LP · Jan 2008
TILITE AERO X
K072311 · Tisport, LLC · Sep 2007
K080207 · DANYANG HUAYI K2 AND K7 WHEELCHAIRS
Download PDF FDA Summary Danyang Huayi Medical…