Cleared Traditional

SYS*STIM 220

K883080 · Mettler Electronics Corp. · Neurology
Apr 1989
Decision
280d
Days
Class 2
Risk

About This 510(k) Submission

K883080 is an FDA 510(k) clearance for the SYS*STIM 220, a Interferential Current Therapy (Class II — Special Controls, product code LIH), submitted by Mettler Electronics Corp. (Anaheim, US). The FDA issued a Cleared decision on April 27, 1989, 280 days after receiving the submission on July 21, 1988. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K883080 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 1988
Decision Date April 27, 1989
Days to Decision 280 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

Product Code LIH — Interferential Current Therapy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5890

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