Cleared Traditional

LARGE MUSCLE STRENGTH GAUGE (K945630) - FDA 510(k) Clearance

Class I Neurology device.

K945630 · J-Tech, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
175d
Days
Class 1
Risk

K945630 is an FDA 510(k) clearance for the LARGE MUSCLE STRENGTH GAUGE. Classified as Goniometer, Ac-powered (product code KQX), Class I - General Controls.

Submitted by J-Tech, Inc. (American Fork, US). The FDA issued a Cleared decision on May 10, 1995 after a review of 175 days - an extended review cycle.

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 J-Tech, Inc. devices

Submission Details

510(k) Number K945630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1994
Decision Date May 10, 1995
Days to Decision 175 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 148d · This submission: 175d
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.