Cleared Traditional

K020100 - SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL WHEELCHAIRS

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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

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
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 K020100.
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
BIOTECH MANUAL WHEELCHAIR, A1000 SUPER SPORT WHEELCHAIR
K020188 · Taiwan Armada Enterprise Co., Ltd. · Mar 2002
BIOTECH MANUAL WHEELCHAIR B900 SUPER LIGHT WHEELCHAIR
K020472 · Taiwan Armada Enterprise Co., Ltd. · Mar 2002
BIOTECH MANUAL WHEELCHAIR A2000 SUPER MOTIVE WHEELCHAIR
K020284 · Taiwan Armada Enterprise Co., Ltd. · Feb 2002