Cleared Traditional

K880032 - MEDEX MACHINE

K880032 is an FDA 510(k) clearance for MEDEX MACHINE, manufactured by Medex, Inc.. The device is a Class 2 Physical Medicine device with product code ISD cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K880032 · Medex, Inc. · Physical Medicine device
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Feb 1988
Decision
37d
Days
Class 2
Risk

K880032 is an FDA 510(k) clearance for the MEDEX MACHINE. Classified as Exerciser, Measuring (product code ISD), Class II - Special Controls.

Submitted by Medex, Inc. (Ocala, US). The FDA issued a Cleared decision on February 11, 1988 after a review of 37 days - a notably fast clearance cycle.

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: 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 Medex, Inc. devices

FDA 510(k) Submission Details - K880032

510(k) Number K880032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1988
Decision Date February 11, 1988
Days to Decision 37 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
78d faster than avg
Panel avg: 115d · This submission: 37d
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 24
Devices cleared under the same product code (ISD) and FDA review panel - the closest regulatory comparables to K880032.
TOTAL WORK INTEGRATOR, MODEL #940-110
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K922606 · Biodan Medical Systems, Ltd. · Jun 1992
MONARK ERGOMETERS
K912227 · Quinton, Inc. · Aug 1991
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