Cleared Traditional

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

K945630 · J-Tech, Inc. · Neurology device

May 1995

Decision

175d

Days

Class 1

Risk

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

Submitted by J-Tech, Inc. (American Fork, US). The FDA issued a Cleared decision on May 10, 1995, 175 days after receiving the submission on November 16, 1994.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 888.1500.

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