Cleared Traditional

NEURO WAVE 6

K062003 · Lhasa Oms, Inc. · Neurology
Sep 2007
Decision
429d
Days
Class 2
Risk

About This 510(k) Submission

K062003 is an FDA 510(k) clearance for the NEURO WAVE 6, a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II — Special Controls, product code GZJ), submitted by Lhasa Oms, Inc. (Weymouth, US). The FDA issued a Cleared decision on September 19, 2007, 429 days after receiving the submission on July 17, 2006. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K062003 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 2006
Decision Date September 19, 2007
Days to Decision 429 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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