Cleared Traditional

K994185 - MANUAL WHEELCHAIR

K994185 is an FDA 510(k) clearance for MANUAL WHEELCHAIR, manufactured by Major Mobility Products, Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K994185 · Major Mobility Products, Inc. · Physical Medicine device
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Jan 2000
Decision
34d
Days
Class 1
Risk

K994185 is an FDA 510(k) clearance for the MANUAL WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Major Mobility Products, Inc. (Houston, US). The FDA issued a Cleared decision on January 13, 2000 after a review of 34 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 Major Mobility Products, Inc. devices

FDA 510(k) Submission Details - K994185

510(k) Number K994185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1999
Decision Date January 13, 2000
Days to Decision 34 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
81d faster than avg
Panel avg: 115d · This submission: 34d
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 K994185.
MODEL 9000 PEDIATRIC WHEELCHAIR
K002170 · Invacare Corp. · Aug 2000
ACTION AF-1 WHEELCHAIR
K000174 · Invacare Corp. · Feb 2000
SIGMA MANUAL WHEELCHAIR
K993963 · Sigma Distribution & Supply, Inc. · Jan 2000
E Z CHAIR
K993298 · Premier Designs · Nov 1999
SPECTRUM LIBRE WHEELCHAIR
K993640 · Freedom Designs, Inc. · Nov 1999
TONICROSS TRICYCLES, MODELS, T0, T1,T2,T3 AND T4.
K992310 · Rupiani Medical · Nov 1999