Cleared Traditional

K851967 - TORQUE FEEDBACK METER

K851967 is the FDA 510(k) clearance for TORQUE FEEDBACK METER by Th Charters, Inc.. It is a Class 2 Physical Medicine device (product code ISD) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K851967 · Th Charters, Inc. · Physical Medicine device
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Jul 1985
Decision
74d
Days
Class 2
Risk

K851967 is an FDA 510(k) clearance for the TORQUE FEEDBACK METER. Classified as Exerciser, Measuring (product code ISD), Class II - Special Controls.

Submitted by Th Charters, Inc. (Beaverton, US). The FDA issued a Cleared decision on July 19, 1985 after a review of 74 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 Th Charters, Inc. devices

Submission Details

510(k) Number K851967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1985
Decision Date July 19, 1985
Days to Decision 74 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
41d faster than avg
Panel avg: 115d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K851967.
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