Cleared Traditional

INTELECT

K974497 · Chattanooga Group, Inc. · Neurology
Jan 1998
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K974497 is an FDA 510(k) clearance for the INTELECT, a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II — Special Controls, product code GZJ), submitted by Chattanooga Group, Inc. (Hixson, US). The FDA issued a Cleared decision on January 23, 1998, 56 days after receiving the submission on November 28, 1997. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K974497 FDA.gov
FDA Decision Cleared SESE
Date Received November 28, 1997
Decision Date January 23, 1998
Days to Decision 56 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

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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