DEVICE: Easy@Home Mini Wireless TENS Pulse Stimulator Replacement Pads (00855944007659)
Device Identifier (DI) Information
Easy@Home Mini Wireless TENS Pulse Stimulator Replacement Pads
ETP015
In Commercial Distribution
EASY HEALTHCARE CORPORATION
ETP015
In Commercial Distribution
EASY HEALTHCARE CORPORATION
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No |
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? |
---|---|---|---|---|
59689 | Neuromuscular transmission electrode |
A non-sterile electrical conductor designed to be applied to a patient's body surface, typically the forearm or ankle, to deliver stimulating electrical pulses to a motor nerve or measure electrical impulses from the nerve during neuromuscular transmission (NMT) monitoring. It is typically a disk-like electrode that is affixed to the skin with a special adhesive and a conductive gel (pre-gelled) intended to be used for neuromuscular block monitoring and nerve stimulation for brachial plexus anaesthesia. This is a single-use device.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K141260 | 000 |
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
d97d5f3f-49c4-4e6b-9db9-75dc2ae4a27c
August 08, 2019
1
July 31, 2019
August 08, 2019
1
July 31, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10855944007656 | 30 | 00855944007659 | In Commercial Distribution | Carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
90855944007652
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined