AVCOO EB2010C21

GUDID 00860012809837

The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface between the patient’s skin and the marketed electrical stimulators (i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current. The electrode is for OTC (Over-The-Counter) or Prescription use.

ADP HEALTH LIMITED

Interferential electrical stimulation system electrode

• Primary Device ID: 00860012809837
• NIH Device Record Key: f674b946-0c22-4ce5-833b-71ebdc01f1a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AVCOO
• Version Model Number: EB2010
• Catalog Number: EB2010C21
• Company DUNS: 101747972
• Company Name: ADP HEALTH LIMITED
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860012809837 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160138

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: 2024-10-07
• Device Publish Date: 2024-09-27

On-Brand Devices [AVCOO]

• 00860012809875: Transcutaneous Electrical Nerve Stimulation (TENS): To be used for temporary relief of pain asso
• 00860012809868: Transcutaneous Electrical Nerve Stimulation (TENS): To be used for temporary relief of pain asso
• 00860012809851: Transcutaneous Electrical Nerve Stimulation (TENS): To be used for temporary relief of pain asso
• 00860012809844: Transcutaneous Electrical Nerve Stimulation (TENS): To be used for temporary relief of pain asso
• 00860012809806: TENS: The device is designed to be used for temporary relief of pain associated with sore and ac
• 00860011737926: TENS: The device is designed to be used for temporary relief of pain associated with sore and ac
• 00860011737919: TENS: The device is designed to be used for temporary relief of pain associated with sore and ac
• 00860012809837: The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface betwee
• 00860012809820: The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface betwee
• 00860012809813: The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface betwee
• 00860011737940: TENS: The device is designed to be used for temporary relief of pain associated with sore and ac
• 00860011737964: TENS: The device is designed to be used for temporary relief of pain associated with sore and ac
• 00860011737957: TENS: The device is designed to be used for temporary relief of pain associated with sore and ac