Cleared Traditional

K770240 - TREADMILL STRESS EXERCISE SYSTEM

K770240 is an FDA 510(k) clearance for TREADMILL STRESS EXERCISE SYSTEM, manufactured by Burdick Corp.. The device is a Class 1 Physical Medicine device with product code IOL cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K770240 · Burdick Corp. · Physical Medicine device
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Feb 1977
Decision
7d
Days
Class 1
Risk

K770240 is an FDA 510(k) clearance for the TREADMILL STRESS EXERCISE SYSTEM. Classified as Treadmill, Powered (product code IOL), Class I - General Controls.

Submitted by Burdick Corp. (Mchenry, US). The FDA issued a Cleared decision on February 14, 1977 after a review of 7 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 Burdick Corp. devices

FDA 510(k) Submission Details - K770240

510(k) Number K770240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1977
Decision Date February 14, 1977
Days to Decision 7 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
108d faster than avg
Panel avg: 115d · This submission: 7d
Pathway characteristics
Predicate-based equivalence.

IOL Device Classification - Class 1, General Controls

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 19
Devices cleared under the same product code (IOL) and FDA review panel - the closest regulatory comparables to K770240.
SERIES 1800 EXERCISE TREADMILL
K802836 · Marquette Electronics, Inc. · Dec 1980
AP-1 AUTO PROGRAMMER
K792590 · Burdick Corp. · Jan 1980
CARDIO-EXERCISE TREADMILL 550
K771697 · Quinton, Inc. · Sep 1977
POWERED TREADMILL (20/ST)
K761040 · Physio-Control Corp. · Dec 1976
POWERED TREADMILL (30/ST)
K761041 · Physio-Control Corp. · Dec 1976
TREADMILL (TMS-300)
K760275 · Burdick Corp. · Aug 1976