Cleared Traditional

SYS STIM 226

K964028 · Mettler Electronics Corp. · Physical Medicine
Feb 1997
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K964028 is an FDA 510(k) clearance for the SYS STIM 226, 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 February 3, 1997, 119 days after receiving the submission on October 7, 1996. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number K964028 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 1996
Decision Date February 03, 1997
Days to Decision 119 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code IPF — Stimulator, Muscle, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5850