Cleared Traditional

K897178 - DYNATRON 360 RANGE OF MOTION TESTING DEVICE

K897178 is an FDA 510(k) clearance for DYNATRON 360 RANGE OF MOTION TESTING DEVICE, manufactured by Dynatronics Corp.. The device is a Class 1 Neurology device with product code KQX cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K897178 · Dynatronics Corp. · Neurology device
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Apr 1990
Decision
112d
Days
Class 1
Risk

K897178 is an FDA 510(k) clearance for the DYNATRON 360 RANGE OF MOTION TESTING DEVICE. Classified as Goniometer, Ac-powered (product code KQX), Class I - General Controls.

Submitted by Dynatronics Corp. (Salt Lake City, US). The FDA issued a Cleared decision on April 18, 1990 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.1500 - 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K897178

510(k) Number K897178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1989
Decision Date April 18, 1990
Days to Decision 112 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
37d faster than avg
Panel avg: 149d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

KQX Device Classification - Class 1, General Controls

Product Code KQX Goniometer, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.1500
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 - KQX Goniometer, Ac-powered

All 21
Devices cleared under the same product code (KQX) and FDA review panel - the closest regulatory comparables to K897178.
ROMAS (RANGE OF MOTION ASSESSMENT SYSTEM)
K922550 · Verimed Holdings, Inc. · Dec 1992
SPINE MOTION ANALYZER WITH EMG
K920256 · Orthopedic Systems, Inc. · Aug 1992
02810-01/02810-02 ORTHORANGER II/02810-3 ROM 360
K913079 · Lucas Sensing Systems, Inc. · Sep 1991
COMPREHENSIVE SPINE MOTION ANALYZER
K894283 · Orthopedic Systems, Inc. · Jan 1990
KRONAMAX KUBE
K893903 · Physicians Digital Co. · Nov 1989
THE HANDSCAN SYSTEM
K893455 · Digital Body Systems, Inc. · Aug 1989
K897178 · DYNATRON 360 RANGE OF MOTION TESTING DEVICE
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