ES-130

Primary DI
04983087008403
Brand
ES-130
Company
ITO CO., LTD.
Model
ES-130
Catalog number
ES-130
Device description
Electro Acupuncture Therapy Unit
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BWKStimulator, Electro-Acupuncture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWKStimulator, Electro-AcupunctureUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081943000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081943000MODEL ES-130Ito Co., Ltd.2008-11-24BWK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14983087008400PackageGS120In Commercial Distribution
24983087008407PackageGS12In Commercial Distribution
04983087008403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1498308700840014983087008400
2498308700840724983087008407
04983087008403049830870084034983087008403

GMDN Terms#

Term, Definition table
TermDefinition
Acupuncture electrical stimulation systemAn electrically-powered unit designed to be used specifically to apply electrical stimuli to acupuncture sites (electroacupuncture). It is an external low-intensity, low frequency pulse (usually 1 to 100 pulses per second), multimode generator intended to connect to acupuncture electrodes. The electrodes may be placed either on the skin, or through acupuncture needles that penetrate the skin at the acupuncture points. Some may use a probe to detect the acupuncture sites using visual or audio signals.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690637194
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04983087007932TM-400TM-400TM-4002016-09-24
04983087012394D functionD function2021-09-09
04983087008496ES-160ES-160ES-1602016-09-24

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Primary DI, Brand, Company table
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