Cleared Traditional

K862741 - Q50 MEDICAL TREADMILL

K862741 is the FDA 510(k) clearance for Q50 MEDICAL TREADMILL by Quinton, Inc.. It is a Class 1 Physical Medicine device (product code IOL) cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K862741 · Quinton, Inc. · Physical Medicine device
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Jul 1986
Decision
8d
Days
Class 1
Risk

K862741 is an FDA 510(k) clearance for the Q50 MEDICAL TREADMILL. Classified as Treadmill, Powered (product code IOL), Class I - General Controls.

Submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on July 29, 1986 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5380 - 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 Quinton, Inc. devices

Submission Details

510(k) Number K862741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1986
Decision Date July 29, 1986
Days to Decision 8 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 115d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IOL Treadmill, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5380
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 - IOL Treadmill, Powered

All 17
Devices cleared under the same product code (IOL) and FDA review panel - the closest regulatory comparables to K862741.
MODIFIED Q-SERIES OF TREADMILLS
K885062 · Quinton, Inc. · Dec 1988
MODEL Q55XT POWERED TREADMILL
K864013 · Quinton, Inc. · Nov 1986
MODIFIED Q50 MEDICAL TREADMILL
K863299 · Quinton, Inc. · Sep 1986
R1596 POWERED EXERCISE EQUIPMENT
K861347 · Tri W-G, Inc. · May 1986
TREADMILL E-17
K850044 · Del Mar Avionics · Apr 1985
PROGRAM. TREADMILL CONTROLLER #645
K830146 · Quinton, Inc. · Feb 1983