Cleared Traditional

K771697 - CARDIO-EXERCISE TREADMILL 550

K771697 is the FDA 510(k) clearance for CARDIO-EXERCISE TREADMILL 550 by Quinton, Inc.. It is a Class 1 Physical Medicine device (product code IOL) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K771697 · Quinton, Inc. · Physical Medicine device
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Sep 1977
Decision
14d
Days
Class 1
Risk

K771697 is an FDA 510(k) clearance for the CARDIO-EXERCISE TREADMILL 550. Classified as Treadmill, Powered (product code IOL), Class I - General Controls.

Submitted by Quinton, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 20, 1977 after a review of 14 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 K771697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1977
Decision Date September 20, 1977
Days to Decision 14 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
101d faster than avg
Panel avg: 115d · This submission: 14d
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 K771697.
QUINTON Q55 MEDICAL TREADMILL
K820478 · Quinton, Inc. · Mar 1982
SERIES 1800 EXERCISE TREADMILL
K802836 · Marquette Electronics, Inc. · Dec 1980
AP-1 AUTO PROGRAMMER
K792590 · Burdick Corp. · Jan 1980
TREADMILL STRESS EXERCISE SYSTEM
K770240 · Burdick Corp. · Feb 1977
POWERED TREADMILL (20/ST)
K761040 · Physio-Control Corp. · Dec 1976
POWERED TREADMILL (30/ST)
K761041 · Physio-Control Corp. · Dec 1976