Cleared Traditional

POINTER PLUS

K060508 · Lhasa Oms, Inc. · Neurology
Jun 2006
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K060508 is an FDA 510(k) clearance for the POINTER PLUS, 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 June 19, 2006, 112 days after receiving the submission on February 27, 2006. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K060508 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 2006
Decision Date June 19, 2006
Days to Decision 112 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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