Cleared Traditional

INTELECT 600MP

K920260 · Chattanooga Group, Inc. · Neurology
Oct 1992
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K920260 is an FDA 510(k) clearance for the INTELECT 600MP, 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 October 13, 1992, 266 days after receiving the submission on January 21, 1992. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K920260 FDA.gov
FDA Decision Cleared SESE
Date Received January 21, 1992
Decision Date October 13, 1992
Days to Decision 266 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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