DEVICE: Omron Electrotherapy Pain Relief Long Life Pads (00073796226145)
Device Identifier (DI) Information
Omron Electrotherapy Pain Relief Long Life Pads
PMLLPAD
In Commercial Distribution
PMLLPAD
Omron Healthcare, Inc.
PMLLPAD
In Commercial Distribution
PMLLPAD
Omron Healthcare, Inc.
Electrotherapy Pain Relief Long Life Pads
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? |
---|---|---|---|---|
35995 | Transcutaneous electrical stimulation electrode, single-use |
An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GXY | Electrode, Cutaneous |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K120516 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Storage Environment Temperature: between -20 and 60 Degrees Celsius |
Storage Environment Temperature: between -4 and 104 Degrees Fahrenheit |
Handling Environment Humidity: between 30 and 40 Percent (%) Relative Humidity |
Handling Environment Temperature: between 15 and 40 Degrees Celsius |
Handling Environment Temperature: between 41 and 104 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
f572c38b-e7af-438f-9c55-a0128008e9cf
June 12, 2025
5
May 17, 2017
June 12, 2025
5
May 17, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10073796226142 | 12 | 00073796226145 | In Commercial Distribution | Inner Carton | |
20073796226149 | 4 | 10073796226142 | In Commercial Distribution | Case | |
50073796226140 | 8 | 00073796226145 | In Commercial Distribution | boxes of 6 units |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-634-4350
ohiquality@omron.com
ohiquality@omron.com