Cleared Traditional

K021145 - ACCOMMODATOR WHEELCHAIR, MODEL #2000X

K021145 is an FDA 510(k) clearance for ACCOMMODATOR WHEELCHAIR, manufactured by Marken International, Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K021145 · Marken International, Inc. · Physical Medicine device
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May 2002
Decision
37d
Days
Class 1
Risk

K021145 is an FDA 510(k) clearance for the ACCOMMODATOR WHEELCHAIR, MODEL #2000X. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Marken International, Inc. (Bozeman, US). The FDA issued a Cleared decision on May 16, 2002 after a review of 37 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 - K021145

510(k) Number K021145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2002
Decision Date May 16, 2002
Days to Decision 37 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
79d faster than avg
Panel avg: 116d · This submission: 37d
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 466
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K021145.
MANUAL WHEELCHAIR
K022825 · Major Mobility Products, Inc. · Sep 2002
MECHANICAL DAILY USE WHEELCHAIR
K021075 · First World Services, Inc. · Jul 2002
KARMA 800 SERIES MANUAL WHEELCHAIR
K021866 · Vestil Manufacturing Corp. · Jun 2002
CAT ACTIVE WHEELCHAIR
K020737 · Movingpeople.Net · Mar 2002
GAZELLE WHEELCHAIR
K020536 · Alum Creek Wheelchair Co., Inc. · Mar 2002
COMFORT WHEELCHAIRS
K020451 · Comfort Orthopedic Co., Ltd. · Mar 2002
K021145 · ACCOMMODATOR WHEELCHAIR, MODEL #2000X
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