Pain Warrior 77621

GUDID 00860001588316

TENS: The device is intended to be used for the temporary relief of pain associated with sore and aching muscles in the lower back, upper extremities (arms) and lower extremities (legs) due to strain from and/or normal non-commercial household work activities. Programs 01 to 07, and HAN are TENS programs. NMES: The device is intended to be used to stimulate healthy muscles in order to facilitate and improve muscle performance. Programs 08 to 13 are NMES programs. The device should be used for these purposes

International Trade Group Inc

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00860001588316
• NIH Device Record Key: 6d336564-07e9-4067-b544-76f94493d65b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pain Warrior
• Version Model Number: ECS322
• Catalog Number: 77621
• Company DUNS: 079427100
• Company Name: International Trade Group 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 6146572881
• Email: bcr88@frontier.com
• Phone: 6146572881
• Email: bcr88@frontier.com
• Phone: 6146572881
• Email: bcr88@frontier.com
• Phone: 6146572881
• Email: bcr88@frontier.com
• Phone: 6146572881
• Email: bcr88@frontier.com
• Phone: 6146572881
• Email: bcr88@frontier.com
• Phone: 6146572881
• Email: bcr88@frontier.com
• Phone: 6146572881
• Email: bcr88@frontier.com
• Phone: 6146572881
• Email: bcr88@frontier.com
• Phone: 6146572881
• Email: bcr88@frontier.com
• Phone: 6146572881
• Email: bcr88@frontier.com
• Phone: 6146572881
• Email: bcr88@frontier.com
• Phone: 6146572881
• Email: bcr88@frontier.com
• Phone: 6146572881
• Email: bcr88@frontier.com
• Phone: 6146572881
• Email: bcr88@frontier.com
• Phone: 6146572881
• Email: bcr88@frontier.com
• Phone: 6146572881
• Email: bcr88@frontier.com
• Phone: 6146572881
• Email: bcr88@frontier.com

Device Dimensions

• Weight: 0.09 Kilogram
• Height: 106 Millimeter
• Width: 62 Millimeter
• Depth: 62 Millimeter
• Weight: 0.09 Kilogram
• Height: 106 Millimeter
• Width: 62 Millimeter
• Depth: 62 Millimeter
• Weight: 0.09 Kilogram
• Height: 106 Millimeter
• Width: 62 Millimeter
• Depth: 62 Millimeter
• Weight: 0.09 Kilogram
• Height: 106 Millimeter
• Width: 62 Millimeter
• Depth: 62 Millimeter
• Weight: 0.09 Kilogram
• Height: 106 Millimeter
• Width: 62 Millimeter
• Depth: 62 Millimeter
• Weight: 0.09 Kilogram
• Height: 106 Millimeter
• Width: 62 Millimeter
• Depth: 62 Millimeter
• Weight: 0.09 Kilogram
• Height: 106 Millimeter
• Width: 62 Millimeter
• Depth: 62 Millimeter
• Weight: 0.09 Kilogram
• Height: 106 Millimeter
• Width: 62 Millimeter
• Depth: 62 Millimeter
• Weight: 0.09 Kilogram
• Height: 106 Millimeter
• Width: 62 Millimeter
• Depth: 62 Millimeter
• Weight: 0.09 Kilogram
• Height: 106 Millimeter
• Width: 62 Millimeter
• Depth: 62 Millimeter
• Weight: 0.09 Kilogram
• Height: 106 Millimeter
• Width: 62 Millimeter
• Depth: 62 Millimeter
• Weight: 0.09 Kilogram
• Height: 106 Millimeter
• Width: 62 Millimeter
• Depth: 62 Millimeter
• Weight: 0.09 Kilogram
• Height: 106 Millimeter
• Width: 62 Millimeter
• Depth: 62 Millimeter
• Weight: 0.09 Kilogram
• Height: 106 Millimeter
• Width: 62 Millimeter
• Depth: 62 Millimeter
• Weight: 0.09 Kilogram
• Height: 106 Millimeter
• Width: 62 Millimeter
• Depth: 62 Millimeter
• Weight: 0.09 Kilogram
• Height: 106 Millimeter
• Width: 62 Millimeter
• Depth: 62 Millimeter
• Weight: 0.09 Kilogram
• Height: 106 Millimeter
• Width: 62 Millimeter
• Depth: 62 Millimeter
• Weight: 0.09 Kilogram
• Height: 106 Millimeter
• Width: 62 Millimeter
• Depth: 62 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001588316 [Primary]

FDA Product Code

• 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: 2023-10-20
• Device Publish Date: 2023-10-12

Devices Manufactured by International Trade Group Inc

• 00860001588309 - Golden State Medical HD Combo: 2023-10-20 GSM HD Combo Transcutaneous Electrical Nerve Stimulation (TENS): The device is intended for the temporary relief of pain associa
• 00860001588316 - Pain Warrior: 2023-10-20TENS: The device is intended to be used for the temporary relief of pain associated with sore and aching muscles in the lower back, upper extremities (arms) and lower extremities (legs) due to strain from and/or normal non-commercial household work activities. Programs 01 to 07, and HAN are TENS programs. NMES: The device is intended to be used to stimulate healthy muscles in order to facilitate and improve muscle performance. Programs 08 to 13 are NMES programs. The device should be used for these purposes
• 00860001588316 - Pain Warrior: 2023-10-20 TENS: The device is intended to be used for the temporary relief of pain associated with sore and aching muscles in the lower ba