Cleared Traditional

K012492 - KADANCE 2000
(FDA 510(k) Clearance)

K012492 · Kada Research, Inc. · Neurology

Nov 2001

Decision

91d

Days

Class 2

Risk

K012492 is an FDA 510(k) clearance for the KADANCE 2000. This device is classified as a Dynamometer, Ac-powered (Class II — Special Controls, product code LBB).

Submitted by Kada Research, Inc. (Houston, US). The FDA issued a Cleared decision on November 2, 2001, 91 days after receiving the submission on August 3, 2001.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 888.1240.

Submission Details

510(k) Number	K012492 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 03, 2001
Decision Date	November 02, 2001
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF