Cleared Traditional

RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R

K091055 · Rhythmlink International, LLC · Neurology
Jun 2009
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K091055 is an FDA 510(k) clearance for the RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R, a Electrode, Needle, Diagnostic Electromyograph (Class II — Special Controls, product code IKT), submitted by Rhythmlink International, LLC (Columbia, US). The FDA issued a Cleared decision on June 23, 2009, 71 days after receiving the submission on April 13, 2009. This device falls under the Neurology review panel. Regulated under 21 CFR 890.1385.

Submission Details

510(k) Number K091055 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 2009
Decision Date June 23, 2009
Days to Decision 71 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code IKT — Electrode, Needle, Diagnostic Electromyograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.1385

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