Cleared Traditional

NEUROTENS

K896620 · Henley Intl. · Neurology
Apr 1990
Decision
156d
Days
Class 2
Risk

About This 510(k) Submission

K896620 is an FDA 510(k) clearance for the NEUROTENS, a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II — Special Controls, product code GZJ), submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on April 26, 1990, 156 days after receiving the submission on November 21, 1989. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K896620 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 1989
Decision Date April 26, 1990
Days to Decision 156 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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