Cleared Traditional

JTECH COMMANDER AND ALGOMETER (K971407) - FDA 510(k) Clearance

Class I Neurology device.

K971407 · J-Tech Medical, Inc. · Neurology device
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Apr 1998
Decision
369d
Days
Class 1
Risk

K971407 is an FDA 510(k) clearance for the JTECH COMMANDER AND ALGOMETER. Classified as Dynamometer, Nonpowered (product code HRW), Class I - General Controls.

Submitted by J-Tech Medical, Inc. (Heber City, US). The FDA issued a Cleared decision on April 20, 1998 after a review of 369 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.1250 - the FDA neurology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all J-Tech Medical, Inc. devices

Submission Details

510(k) Number K971407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1997
Decision Date April 20, 1998
Days to Decision 369 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
221d slower than avg
Panel avg: 148d · This submission: 369d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HRW Dynamometer, Nonpowered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.1250
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HRW Dynamometer, Nonpowered

All 11
Devices cleared under the same product code (HRW) and FDA review panel - the closest regulatory comparables to K971407.
PINCH GAUGE, 0-301 LBS.
K821631 · Fred Sammons, Inc. · Jun 1982
PINCH METER
K812343 · Fred Sammons, Inc. · Sep 1981
BK-7531 PAIN THRESHOLD/FINGER FORCE GAUG
K801719 · Fred Sammons, Inc. · Aug 1980
PINCH GUAGE
K772413 · Fred Sammons, Inc. · Jan 1978
DYNAMETER 50 LB.
K772415 · Fred Sammons, Inc. · Jan 1978
JAMAR DYNAMOMETEO BK-7498
K771288 · Fred Sammons, Inc. · Jul 1977