Cleared Traditional

K081943 - MODEL ES-130 (FDA 510(k) Clearance)

K081943 · Ito Co., Ltd. · Neurology device
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Optimized for regulatory review, auditing and printing
Nov 2008
Decision
139d
Days
-
Risk

K081943 is an FDA 510(k) clearance for the MODEL ES-130. Classified as Stimulator, Electro-acupuncture (product code BWK).

Submitted by Ito Co., Ltd. (Richardson, US). The FDA issued a Cleared decision on November 24, 2008 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ito Co., Ltd. devices

Submission Details

510(k) Number K081943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 148d · This submission: 139d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BWK Stimulator, Electro-acupuncture
Device Class -

Regulatory Peers - BWK Stimulator, Electro-acupuncture

All 22
Devices cleared under the same product code (BWK) and FDA review panel - the closest regulatory comparables to K081943.
Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)
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Needle Stimulator (Model: RJNS6-1)
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Needle Stimulator
K202861 · Wuxi Jiajian Medical Instrument Co., Ltd. · Aug 2021
AXUS ES-5 Electro-Acupuncture Device
K200636 · Lhasa Oms, Inc. · Feb 2021