Cleared Traditional

CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000

K033358 · Surgitech, Inc. · Neurology

Nov 2003

Decision

25d

Days

Class 2

Risk

About This 510(k) Submission

K033358 is an FDA 510(k) clearance for the CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000, a Interferential Current Therapy (Class II — Special Controls, product code LIH), submitted by Surgitech, Inc. (Oceanside, US). The FDA issued a Cleared decision on November 14, 2003, 25 days after receiving the submission on October 20, 2003. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K033358 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 20, 2003
Decision Date	November 14, 2003
Days to Decision	25 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF