Cleared Traditional

K993963 - SIGMA MANUAL WHEELCHAIR

K993963 is an FDA 510(k) clearance for SIGMA MANUAL WHEELCHAIR, manufactured by Sigma Distribution & Supply, Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K993963 · Sigma Distribution & Supply, Inc. · Physical Medicine device
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Jan 2000
Decision
52d
Days
Class 1
Risk

K993963 is an FDA 510(k) clearance for the SIGMA MANUAL WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Sigma Distribution & Supply, Inc. (Glendale, US). The FDA issued a Cleared decision on January 13, 2000 after a review of 52 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 Sigma Distribution & Supply, Inc. devices

FDA 510(k) Submission Details - K993963

510(k) Number K993963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1999
Decision Date January 13, 2000
Days to Decision 52 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
63d faster than avg
Panel avg: 115d · This submission: 52d
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 157
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K993963.
MODEL 9000 BARIATRIC WHEELCHAIR
K002317 · Invacare Corp. · Aug 2000
MODEL 9000 PEDIATRIC WHEELCHAIR
K002170 · Invacare Corp. · Aug 2000
ACTION AF-1 WHEELCHAIR
K000174 · Invacare Corp. · Feb 2000
MANUAL WHEELCHAIR
K994185 · Major Mobility Products, Inc. · Jan 2000
E Z CHAIR
K993298 · Premier Designs · Nov 1999
SPECTRUM LIBRE WHEELCHAIR
K993640 · Freedom Designs, Inc. · Nov 1999