Cleared Traditional

K022825 - MANUAL WHEELCHAIR

K022825 is an FDA 510(k) clearance for MANUAL WHEELCHAIR, manufactured by Major Mobility Products, Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K022825 · Major Mobility Products, Inc. · Physical Medicine device
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Sep 2002
Decision
18d
Days
Class 1
Risk

K022825 is an FDA 510(k) clearance for the MANUAL WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Major Mobility Products, Inc. (Richmond, US). The FDA issued a Cleared decision on September 13, 2002 after a review of 18 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 - K022825

510(k) Number K022825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2002
Decision Date September 13, 2002
Days to Decision 18 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 116d · This submission: 18d
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 452
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K022825.
COMFY HIGH RISER WHEELCHAIR
K022617 · Lenjoy Medical Engineering, Inc. · Sep 2002
TRANSFER COMPANION HR 3000 MANUAL WHEELCHAIR
K022699 · Forever Young Ent. Co., Ltd. · Sep 2002
DELUXE MANUAL WHEELCHAIR HW 4000
K022700 · Forever Young Ent. Co., Ltd. · Sep 2002
MECHANICAL DAILY USE WHEELCHAIR
K021075 · First World Services, Inc. · Jul 2002
KARMA 800 SERIES MANUAL WHEELCHAIR
K021866 · Vestil Manufacturing Corp. · Jun 2002
ACCOMMODATOR WHEELCHAIR, MODEL #2000X
K021145 · Marken International, Inc. · May 2002
K022825 · MANUAL WHEELCHAIR
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