Cleared Traditional

K000870 - KM-10 TENS ELECTRODE
(FDA 510(k) Clearance)

K000870 · Katecho, Inc. · Neurology

Nov 2000

Decision

232d

Days

Class 2

Risk

K000870 is an FDA 510(k) clearance for the KM-10 TENS ELECTRODE. This device is classified as a Electrode, Cutaneous (Class II — Special Controls, product code GXY).

Submitted by Katecho, Inc. (Des Moines, US). The FDA issued a Cleared decision on November 7, 2000, 232 days after receiving the submission on March 20, 2000.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number	K000870 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 20, 2000
Decision Date	November 07, 2000
Days to Decision	232 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Statement