Cleared Abbreviated

SYS*STIM 240

K113017 · Mettler Electronics Corp. · Physical Medicine

Jun 2012

Decision

259d

Days

Class 2

Risk

About This 510(k) Submission

K113017 is an FDA 510(k) clearance for the SYS*STIM 240, a Stimulator, Muscle, Powered (Class II — Special Controls, product code IPF), submitted by Mettler Electronics Corp. (Anaheim, US). The FDA issued a Cleared decision on June 26, 2012, 259 days after receiving the submission on October 11, 2011. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K113017 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 11, 2011
Decision Date	June 26, 2012
Days to Decision	259 days
Submission Type	Abbreviated
Review Panel	Physical Medicine (PM)
Summary	Summary PDF