Cleared Traditional

K925724 - M100 POWERED WHEELCHAIR

K925724 is an FDA 510(k) clearance for M100 POWERED WHEELCHAIR, manufactured by Mcnally Industries, Inc.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 501-day FDA review.

K925724 · Mcnally Industries, Inc. · Physical Medicine device
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Mar 1994
Decision
501d
Days
Class 2
Risk

K925724 is an FDA 510(k) clearance for the M100 POWERED WHEELCHAIR. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Mcnally Industries, Inc. (Grantsburg, US). The FDA issued a Cleared decision on March 29, 1994 after a review of 501 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Mcnally Industries, Inc. devices

FDA 510(k) Submission Details - K925724

510(k) Number K925724 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 13, 1992
Decision Date March 29, 1994
Days to Decision 501 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
386d slower than avg
Panel avg: 115d · This submission: 501d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITI Device Classification - Class 2, Special Controls

Product Code ITI Wheelchair, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3860
Definition A Powered Wheelchair Is A Battery-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 Require An Assistive Device For Mobility. Note: This Type Of Device Is Not Intended To Climb Stairs (see Product Code: Imk).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - ITI Wheelchair, Powered

All 404
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K925724.
ROAD WARRIOR
K935749 · Redman, Inc. · Jan 1995
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HOVEROUND POWER CHAIR
K932329 · Hoveround Corp. · Mar 1994