Omron Total Power + Heat TENS Unit PM800

GUDID 10073796638006

Omron TENS Therapy Unit with Heat and 9 preset mode, 2 therapy choices and 20 intensity levels.

Omron Healthcare, Inc.

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 10073796638006
• NIH Device Record Key: e4fb52f3-0ebc-46fc-b7c6-e523b376b720
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omron Total Power + Heat TENS Unit
• Version Model Number: PM800
• Catalog Number: PM800
• 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: true
• Manufacturing Date: false
• Expiration Date: true
• 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: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00073796638009 [Primary]
GS1	10073796638006 [Package]; Contains: 00073796638009; Package: Case [12 Units]; In Commercial Distribution
GS1	50073796638004 [Package]; Contains: 00073796638009; Package: Carton [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181992

FDA Product Code

• NYN: Stimulator, Electrical, Transcutaneous, For Arthritis

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-07
• Device Publish Date: 2019-05-06

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