Cleared Traditional

AWQ-104

K050989 · Lhasa Oms, Inc. · Neurology
Apr 2006
Decision
352d
Days
Class 2
Risk

About This 510(k) Submission

K050989 is an FDA 510(k) clearance for the AWQ-104, 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 April 6, 2006, 352 days after receiving the submission on April 19, 2005. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K050989 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2005
Decision Date April 06, 2006
Days to Decision 352 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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