Cleared Traditional

K020094 - 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 is an FDA 510(k) clearance for EN 600-658, manufactured by Regulatory Insight, Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K020094 · Regulatory Insight, Inc. · Physical Medicine device
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Mar 2002
Decision
56d
Days
Class 1
Risk

K020094 is an FDA 510(k) clearance for the EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN 60.... Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Regulatory Insight, Inc. (Littleton, US). The FDA issued a Cleared decision on March 8, 2002 after a review of 56 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 - K020094

510(k) Number K020094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2002
Decision Date March 08, 2002
Days to Decision 56 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
60d faster than avg
Panel avg: 116d · This submission: 56d
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 398
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K020094.
CAT ACTIVE WHEELCHAIR
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K020536 · Alum Creek Wheelchair Co., Inc. · Mar 2002
COMFORT WHEELCHAIRS
K020451 · Comfort Orthopedic Co., Ltd. · Mar 2002
SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL WHEELCHAIRS
K020100 · Regulatory Insight, Inc. · Mar 2002
BIOTECH MANUAL WHEELCHAIR, A1000 SUPER SPORT WHEELCHAIR
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BIOTECH MANUAL WHEELCHAIR B900 SUPER LIGHT WHEELCHAIR
K020472 · Taiwan Armada Enterprise Co., Ltd. · Mar 2002