Cleared Traditional

K040561 - MANUAL WHEELCHAIR SERIES

K040561 is an FDA 510(k) clearance for MANUAL WHEELCHAIR SERIES, manufactured by Shanghai Wheelchair Factory. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K040561 · Shanghai Wheelchair Factory · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
28d
Days
Class 1
Risk

K040561 is an FDA 510(k) clearance for the MANUAL WHEELCHAIR SERIES. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Shanghai Wheelchair Factory (Grand Rapids, US). The FDA issued a Cleared decision on March 31, 2004 after a review of 28 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 - K040561

510(k) Number K040561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2004
Decision Date March 31, 2004
Days to Decision 28 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
88d faster than avg
Panel avg: 116d · This submission: 28d
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 465
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K040561.
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K040561 · MANUAL WHEELCHAIR SERIES
Download PDF FDA Summary Shanghai Wheelchair F…