Cleared Traditional

K861396 - HANDHELD DYNAMOMETER, MODEL #160 AND #111

K861396 is an FDA 510(k) clearance for HANDHELD DYNAMOMETER, manufactured by Spark Instruments & Academics, Inc.. The device is a Class 1 Neurology device with product code HRW cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K861396 · Spark Instruments & Academics, Inc. · Neurology device
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May 1986
Decision
17d
Days
Class 1
Risk

K861396 is an FDA 510(k) clearance for the HANDHELD DYNAMOMETER, MODEL #160 AND #111. Classified as Dynamometer, Nonpowered (product code HRW), Class I - General Controls.

Submitted by Spark Instruments & Academics, Inc. (Coralville, US). The FDA issued a Cleared decision on May 2, 1986 after a review of 17 days - a notably fast clearance cycle.

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: 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 Spark Instruments & Academics, Inc. devices

FDA 510(k) Submission Details - K861396

510(k) Number K861396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1986
Decision Date May 02, 1986
Days to Decision 17 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d faster than avg
Panel avg: 148d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

HRW Device Classification - Class 1, General Controls

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 8
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