Cleared Traditional

ACUTRON MENTOR MODEL 961

K981976 · Microcurrent Research, Inc. · Neurology
Nov 1998
Decision
177d
Days
Class 2
Risk

About This 510(k) Submission

K981976 is an FDA 510(k) clearance for the ACUTRON MENTOR MODEL 961, a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II — Special Controls, product code GZJ), submitted by Microcurrent Research, Inc. (Phoenix, US). The FDA issued a Cleared decision on November 25, 1998, 177 days after receiving the submission on June 1, 1998. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K981976 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 1998
Decision Date November 25, 1998
Days to Decision 177 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GZJ — Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5890

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