Focus Knee Replacement Band - Medium PMKBAND-M

GUDID 20073796124438

Replacement band for the Omron Focus TENS Unit - Medium

Omron Healthcare, Inc.

Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use

Primary Device ID	20073796124438
NIH Device Record Key	9cfdc090-77f1-4119-9ac1-1858f09605e2
Commercial Distribution Status	In Commercial Distribution
Brand Name	Focus Knee Replacement Band - Medium
Version Model Number	PMKBAND-M
Catalog Number	PMKBAND-M
Company DUNS	054318779
Company Name	Omron Healthcare, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Customer Support Contacts

Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com
Phone	800-634-4350
Email	ohiquality@omron.com

Operating and Storage Conditions

Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00073796124434 [Primary]
GS1	10073796124431 [Package] Contains: 00073796124434 Package: Carton [10 Units] In Commercial Distribution
GS1	20073796124438 [Package] Contains: 10073796124431 Package: Case [5 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K183215

FDA Product Code

GXY	Electrode, Cutaneous
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-01-23
Device Publish Date	2020-01-15

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