Cleared Traditional

THERAPEUTIC ULTRASOUND AND STIMULATOR

K935324 · Chattanooga Group, Inc. · Neurology
May 1994
Decision
202d
Days
Class 2
Risk

About This 510(k) Submission

K935324 is an FDA 510(k) clearance for the THERAPEUTIC ULTRASOUND AND STIMULATOR, 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 May 26, 1994, 202 days after receiving the submission on November 5, 1993. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K935324 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 1993
Decision Date May 26, 1994
Days to Decision 202 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

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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