Cleared Traditional

MUSCLE TESTING GUN (K791021) - FDA 510(k) Clearance

Class I Neurology device.

K791021 · The Orthodyn Co. · Neurology device
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Jun 1979
Decision
16d
Days
Class 1
Risk

K791021 is an FDA 510(k) clearance for the MUSCLE TESTING GUN. Classified as Dynamometer, Nonpowered (product code HRW), Class I - General Controls.

Submitted by The Orthodyn Co. (Mchenry, US). The FDA issued a Cleared decision on June 15, 1979 after a review of 16 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 The Orthodyn Co. devices

Submission Details

510(k) Number K791021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1979
Decision Date June 15, 1979
Days to Decision 16 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
132d faster than avg
Panel avg: 148d · This submission: 16d
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

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