DEVICE: PowerTENS (06942808221093)
Device Identifier (DI) Information
PowerTENS
PowerTENS
In Commercial Distribution
EasyMed Instruments Co., Ltd.
PowerTENS
In Commercial Distribution
EasyMed Instruments Co., Ltd.
PowerTENS is a Transcutaneous Electrical Nerve Stimulator, which is used to provide symptomatic pain relief for chronic, acute or post operative pain.
Device Characteristics
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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35372 | Analgesic transcutaneous electrical nerve stimulation system |
An assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.
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FDA Product Code
[?]Product Code | Product Code Name |
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GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief |
FDA Premarket Submission
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
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Clinically Relevant Size
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Device Record Status
0b3b7d44-800e-4d03-913d-c3213a476d1f
October 23, 2019
3
December 31, 2016
October 23, 2019
3
December 31, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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Unit of Use DI
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CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined