Cleared Traditional

K081943 - MODEL ES-130

K081943 · Ito Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K081943

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 149d · This submission: 139d
Pathway characteristics
Predicate-based equivalence.

BWK Device Classification - Class 0,

Product Code BWK Stimulator, Electro-acupuncture
Device Class -

Regulatory Peers - BWK Stimulator, Electro-acupuncture

All 18
Devices cleared under the same product code (BWK) and FDA review panel - the closest regulatory comparables to K081943.
MULTI-PURPOSE HEALTH DEVICE
K093322 · Upc Medical Supplies, Inc. Dba United Pacific Co. · Aug 2010
ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01
K091933 · Inno-Health Technology, Inc. · Apr 2010
E-PULSE
K091875 · Medevice Corporation · Dec 2009
P-STIM SYSTEM
K050123 · Neuroscience Therapy Corp. · Mar 2006
ACULIFE, MODEL SMW-01
K051197 · Inno-Health Technology, Inc. · Mar 2006
ACUSTIM
K014273 · S.H.P. Intl. Pty., Ltd. · Jun 2002