Cleared Traditional

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

K914060 · Nk Biotechnical Engineering Co. · Neurology device

Dec 1991

Decision

90d

Days

Class 1

Risk

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

Submitted by Nk Biotechnical Engineering Co. (Minneapolis, US). The FDA issued a Cleared decision on December 9, 1991, 90 days after receiving the submission on September 10, 1991.

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

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