DEVICE: ES-130 (04983087008403)

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Device Identifier (DI) Information

ES-130
ES-130
ES-130
ITO CO., LTD.
04983087008403
GS1
1
Electro Acupuncture Therapy Unit
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Acupuncture electrical stimulation system An assembly of devices used to apply electrical stimuli to acupuncture sites. It typically consists of an external low-intensity, low frequency (usually 1 to 100 pulses per second) pulse, multimode generator and 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.
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FDA Product Code

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Product Code Product Code Name
BWK Stimulator, Electro-Acupuncture
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 24, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
14983087008400 20 04983087008403 In Commercial Distribution
24983087008407 2 14983087008400 In Commercial Distribution
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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