Cleared Traditional

K020100 - SL 803

K020100 is an FDA 510(k) clearance for SL 803, 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.

K020100 · Regulatory Insight, Inc. · Physical Medicine device
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Mar 2002
Decision
56d
Days
Class 1
Risk

K020100 is an FDA 510(k) clearance for the SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL .... 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.

View all Regulatory Insight, Inc. devices

FDA 510(k) Submission Details - K020100

510(k) Number K020100 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
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 115d · 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 98
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K020100.
EXCEL BARIATRIC OR EXCEL SHUTTLE WHEELCHAIR
K051302 · Medline Industries, Inc. · Aug 2005
LITESTREAM 500E
K042444 · Pride Mobility Products Corp. · Oct 2004
KUSCHALL CHAMPION, KUSCHALL COMPACT, KUSCHALL ULTRA-LIGHT
K041072 · Invacare Corporation · May 2004
MEDLINE EXCEL RECLINCER WHEELCHAIR
K013761 · Medline Industries, Inc. · Dec 2001
SOLARA JR. MANUAL WHEELCHAIR
K012370 · Invacare Corp. · Aug 2001
MODEL TOP END TERMINATOR TITANIUM MANUAL WHEELCHAIR
K012167 · Invacare Corp. · Aug 2001