Cleared Traditional

K850869 - MFE COUCH ERGOMETER

K850869 is an FDA 510(k) clearance for MFE COUCH ERGOMETER, manufactured by Ketronic, Inc.. The device is a Class 2 Physical Medicine device with product code ISD cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K850869 · Ketronic, Inc. · Physical Medicine device
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Jun 1985
Decision
103d
Days
Class 2
Risk

K850869 is an FDA 510(k) clearance for the MFE COUCH ERGOMETER. Classified as Exerciser, Measuring (product code ISD), Class II - Special Controls.

Submitted by Ketronic, Inc. (The Netherlands, NL). The FDA issued a Cleared decision on June 12, 1985 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5360 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Ketronic, Inc. devices

FDA 510(k) Submission Details - K850869

510(k) Number K850869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1985
Decision Date June 12, 1985
Days to Decision 103 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
12d faster than avg
Panel avg: 115d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ISD Device Classification - Class 2, Special Controls

Product Code ISD Exerciser, Measuring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5360
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 - ISD Exerciser, Measuring

All 27
Devices cleared under the same product code (ISD) and FDA review panel - the closest regulatory comparables to K850869.
MEDEX MACHINE
K880032 · Medex, Inc. · Feb 1988
RESUBMITTED EXCALIBUR
K880271 · Quinton, Inc. · Feb 1988
R1361 & R1372 MEASURED EXERCISE EQUIPMENT
K861348 · Tri W-G, Inc. · May 1986
UNIVERSAL-ERGOTEST
K843850 · Erich Jaeger, Inc. · Nov 1984
NUCLEAR STRESS TABLE (NST-1)
K800892 · Technicare Corp. · May 1980
STRESS TABLE/ERGOMETER SYSTEM
K792591 · Victoreen, Inc. · Jan 1980