VEINOPLUS SPORT

GUDID 03701084900039

AD REM TECHNOLOGY

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 03701084900039
• NIH Device Record Key: 36971702-0bff-4678-9678-9cec37be6520
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VEINOPLUS SPORT
• Version Model Number: 2.1
• Company DUNS: 273234679
• Company Name: AD REM TECHNOLOGY
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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: +33(0)142600022
• Email: info@veinoplus.com
• Phone: +33(0)142600022
• Email: info@veinoplus.com
• Phone: +33(0)142600022
• Email: info@veinoplus.com
• Phone: +33(0)142600022
• Email: info@veinoplus.com
• Phone: +33(0)142600022
• Email: info@veinoplus.com
• Phone: +33(0)142600022
• Email: info@veinoplus.com
• Phone: +33(0)142600022
• Email: info@veinoplus.com
• Phone: +33(0)142600022
• Email: info@veinoplus.com
• Phone: +33(0)142600022
• Email: info@veinoplus.com
• Phone: +33(0)142600022
• Email: info@veinoplus.com
• Phone: +33(0)142600022
• Email: info@veinoplus.com
• Phone: +33(0)142600022
• Email: info@veinoplus.com
• Phone: +33(0)142600022
• Email: info@veinoplus.com
• Phone: +33(0)142600022
• Email: info@veinoplus.com
• Phone: +33(0)142600022
• Email: info@veinoplus.com
• Phone: +33(0)142600022
• Email: info@veinoplus.com
• Phone: +33(0)142600022
• Email: info@veinoplus.com
• Phone: +33(0)142600022
• Email: info@veinoplus.com
• Phone: +33(0)142600022
• Email: info@veinoplus.com
• Phone: +33(0)142600022
• Email: info@veinoplus.com
• Phone: +33(0)142600022
• Email: info@veinoplus.com
• Phone: +33(0)142600022
• Email: info@veinoplus.com
• Phone: +33(0)142600022
• Email: info@veinoplus.com
• Phone: +33(0)142600022
• Email: info@veinoplus.com
• Phone: +33(0)142600022
• Email: info@veinoplus.com
• Phone: +33(0)142600022
• Email: info@veinoplus.com
• Phone: +33(0)142600022
• Email: info@veinoplus.com
• Phone: +33(0)142600022
• Email: info@veinoplus.com
• Phone: +33(0)142600022
• Email: info@veinoplus.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701084900039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141919

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-09-19

Devices Manufactured by AD REM TECHNOLOGY

• 03701084900008 - VEINOPLUS PACK: 2021-02-19
• 03701084900015 - VEINOPLUS: 2019-10-23
• 03701084900022 - VEINOPLUS DVT: 2019-10-23
• 03701084900039 - VEINOPLUS SPORT: 2019-10-23
• 03701084900039 - VEINOPLUS SPORT: 2019-10-23