Cleared Traditional

VECTRA PRO MODELS 2 AND 4

K982324 · Chattanooga Group, Inc. · Neurology
Feb 1999
Decision
214d
Days
Class 2
Risk

About This 510(k) Submission

K982324 is an FDA 510(k) clearance for the VECTRA PRO MODELS 2 AND 4, 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 February 1, 1999, 214 days after receiving the submission on July 2, 1998. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K982324 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 1998
Decision Date February 01, 1999
Days to Decision 214 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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