Cleared Traditional

K020737 - CAT ACTIVE WHEELCHAIR

K020737 is an FDA 510(k) clearance for CAT ACTIVE WHEELCHAIR, manufactured by Movingpeople.Net. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K020737 · Movingpeople.Net · Physical Medicine device
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Mar 2002
Decision
15d
Days
Class 1
Risk

K020737 is an FDA 510(k) clearance for the CAT ACTIVE WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Movingpeople.Net (Toronto, Ontario, CA). The FDA issued a Cleared decision on March 21, 2002 after a review of 15 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 - K020737

510(k) Number K020737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2002
Decision Date March 21, 2002
Days to Decision 15 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 116d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 Consultant

Tuv America, Inc.
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IOR Wheelchair, Mechanical

All 466
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K020737.
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
GAZELLE WHEELCHAIR
K020536 · Alum Creek Wheelchair Co., Inc. · Mar 2002
COMFORT WHEELCHAIRS
K020451 · Comfort Orthopedic Co., Ltd. · Mar 2002
EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN 600-665 AND EN 600-670 MECHANICAL WHEELCHAIRS
K020094 · Regulatory Insight, Inc. · Mar 2002

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K020737 · CAT ACTIVE WHEELCHAIR
Download PDF Movingpeople.Net