Cleared Traditional

K954376 - MUSTANG

K954376 is an FDA 510(k) clearance for MUSTANG, manufactured by Temco, Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K954376 · Temco, Inc. · Physical Medicine device
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Dec 1995
Decision
80d
Days
Class 1
Risk

K954376 is an FDA 510(k) clearance for the MUSTANG. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Temco, Inc. (Hauppauge, US). The FDA issued a Cleared decision on December 8, 1995 after a review of 80 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 Temco, Inc. devices

FDA 510(k) Submission Details - K954376

510(k) Number K954376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1995
Decision Date December 08, 1995
Days to Decision 80 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
35d faster than avg
Panel avg: 115d · This submission: 80d
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 247
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K954376.
ECLIPSE 600 MANUALLY OPERATED WHEELCHAIR
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BCW ADVANTAGE WHEELCHAIR
K961514 · Wheelchairs of Kansas · May 1996
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K960402 · Metro-Care · Feb 1996
QUICKIE TSR
K952641 · Sunrise Medical, Inc. · Jul 1995
MODELS PHOENIX AND CONCEPT 45 MANUAL MECHANICAL WHEELCHAIRS
K951138 · Invacare Corp. · Mar 1995
SCC22/ SCC26 SHOWER COMMODE CHAIR
K943293 · O'Tec Corp. · Aug 1994