Cleared Traditional

ACUSOURCE 600 (TENS)

K895977 · Microcurrent Research, Inc. · Neurology
Jan 1990
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K895977 is an FDA 510(k) clearance for the ACUSOURCE 600 (TENS), a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II — Special Controls, product code GZJ), submitted by Microcurrent Research, Inc. (New Haven, US). The FDA issued a Cleared decision on January 9, 1990, 89 days after receiving the submission on October 12, 1989. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K895977 FDA.gov
FDA Decision Cleared SESE
Date Received October 12, 1989
Decision Date January 09, 1990
Days to Decision 89 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

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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