Cleared Traditional

K791021 - MUSCLE TESTING GUN

K791021 is an FDA 510(k) clearance for MUSCLE TESTING GUN, manufactured by The Orthodyn Co.. The device is a Class 1 Neurology device with product code HRW cleared through the Traditional 510(k) pathway after a 16-day FDA review.

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.

FDA 510(k) Submission Details - K791021

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d faster than avg
Panel avg: 149d · This submission: 16d
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 11
Devices cleared under the same product code (HRW) and FDA review panel - the closest regulatory comparables to K791021.
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
PRESSURE MONITOR, MODEL 212
K790302 · Zatek · Mar 1979
PINCH GUAGE
K772413 · Fred Sammons, Inc. · Jan 1978
DYNAMETER 50 LB.
K772415 · Fred Sammons, Inc. · Jan 1978
K791021 · MUSCLE TESTING GUN
Download PDF The Orthodyn Co.