Cleared Traditional

K843850 - UNIVERSAL-ERGOTEST

K843850 is an FDA 510(k) clearance for UNIVERSAL-ERGOTEST, manufactured by Erich Jaeger, Inc.. The device is a Class 2 Physical Medicine device with product code ISD cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K843850 · Erich Jaeger, Inc. · Physical Medicine device
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Nov 1984
Decision
57d
Days
Class 2
Risk

K843850 is an FDA 510(k) clearance for the UNIVERSAL-ERGOTEST. Classified as Exerciser, Measuring (product code ISD), Class II - Special Controls.

Submitted by Erich Jaeger, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 27, 1984 after a review of 57 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 Erich Jaeger, Inc. devices

FDA 510(k) Submission Details - K843850

510(k) Number K843850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1984
Decision Date November 27, 1984
Days to Decision 57 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
58d faster than avg
Panel avg: 115d · This submission: 57d
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 16
Devices cleared under the same product code (ISD) and FDA review panel - the closest regulatory comparables to K843850.
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
NUCLEAR STRESS TABLE (NST-1)
K800892 · Technicare Corp. · May 1980
STRESS TABLE/ERGOMETER SYSTEM
K792591 · Victoreen, Inc. · Jan 1980
AUTORANGE
K781997 · Tri W-G, Inc. · Jan 1979