Cleared Traditional

MODEL ES-130

K081943 · Ito Co., Ltd. · Neurology
Nov 2008
Decision
139d
Days
—
Risk

About This 510(k) Submission

K081943 is an FDA 510(k) clearance for the MODEL ES-130, a Stimulator, Electro-acupuncture, submitted by Ito Co., Ltd. (Richardson, US). The FDA issued a Cleared decision on November 24, 2008, 139 days after receiving the submission on July 8, 2008. This device falls under the Neurology review panel.

Submission Details

510(k) Number K081943 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 2008
Decision Date November 24, 2008
Days to Decision 139 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code BWK — Stimulator, Electro-acupuncture
Device Class —

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