Cleared Traditional

K914060 - RANGE OF MOTION SENSOR, MODEL RM001 (FDA 510(k) Clearance)

Class I Neurology device.

K914060 · Nk Biotechnical Engineering Co. · Neurology device
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Dec 1991
Decision
90d
Days
Class 1
Risk

K914060 is an FDA 510(k) clearance for the RANGE OF MOTION SENSOR, MODEL RM001. Classified as Goniometer, Ac-powered (product code KQX), Class I - General Controls.

Submitted by Nk Biotechnical Engineering Co. (Minneapolis, US). The FDA issued a Cleared decision on December 9, 1991 after a review of 90 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.

View all Nk Biotechnical Engineering Co. devices

Submission Details

510(k) Number K914060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1991
Decision Date December 09, 1991
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.