ValuTrode

GUDID 00851913006289

2.0” x 2.0” (5cm x 5 cm) Square Neurostimulation Electrode featuring VELCRO® brand fasteners as the top cover. VELCRO® is a registered trademark of Velcro BVBA.

AXELGAARD MANUFACTURING CO., LTD.

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

• Primary Device ID: 00851913006289
• NIH Device Record Key: 569fab0e-7d66-4498-baf2-781b919fe976
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ValuTrode
• Version Model Number: 180-0040-00
• Company DUNS: 150959401
• Company Name: AXELGAARD MANUFACTURING CO., LTD.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851913006289 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130987

FDA Product Code

• GXY: Electrode, Cutaneous

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: 2018-09-07
• Device Publish Date: 2018-08-07

Devices Manufactured by AXELGAARD MANUFACTURING CO., LTD.

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• 00851913006319 - UltraStim X Blue: 2021-04-21
• 00851913006326 - UltraStim X Blue: 2021-04-21
• 00851913006197 - EconoStim: 2020-01-15 1.2" x 2" (3cm x 5cm) Rectangle
• 00851913006203 - EconoStim: 2020-01-15 2" (5 cm) Round
• 00851913006210 - EconoStim: 2020-01-15 2" x 2" (5cm x 5cm) Square