Cleared Traditional

K781997 - AUTORANGE

K781997 is an FDA 510(k) clearance for AUTORANGE, manufactured by Tri W-G, Inc.. The device is a Class 2 Physical Medicine device with product code ISD cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K781997 · Tri W-G, Inc. · Physical Medicine device
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Jan 1979
Decision
39d
Days
Class 2
Risk

K781997 is an FDA 510(k) clearance for the AUTORANGE. Classified as Exerciser, Measuring (product code ISD), Class II - Special Controls.

Submitted by Tri W-G, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 8, 1979 after a review of 39 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 Tri W-G, Inc. devices

FDA 510(k) Submission Details - K781997

510(k) Number K781997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1978
Decision Date January 08, 1979
Days to Decision 39 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
76d faster than avg
Panel avg: 115d · This submission: 39d
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 K781997.
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
MODEL 880 REHABILITATION TRAINER
K770234 · Quinton, Inc. · Feb 1977
CALIBRATED GRASPING TUBES
K770148 · Maddak, Inc. · Feb 1977