DEVICE: Avazzia (00851530007782)
Device Identifier (DI) Information
Avazzia
A4-AP-K
In Commercial Distribution
A4-AP-K
AVAZZIA INC
A4-AP-K
In Commercial Distribution
A4-AP-K
AVAZZIA INC
Convenience kit with Avazzia Life Pinnacle device, conductive pads, Y electrode accessory, brush electrode accessory, lead wires, batteries, instruction manual and carry case.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
006f7bb6-521b-4253-a606-ba4232af7ec9
December 28, 2021
1
December 20, 2021
December 28, 2021
1
December 20, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined