AVCOO

GUDID 16970890320438

Shenzhen As-Tec Technology Co.,Ltd.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 16970890320438
• NIH Device Record Key: af51f89b-36b9-4933-be4e-9298ec8128d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AVCOO
• Version Model Number: AS8019
• Company DUNS: 421355284
• Company Name: Shenzhen As-Tec Technology 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: 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: +8675525030234
• Email: sales5@szastec.com
• Phone: +8675525030234
• Email: sales5@szastec.com
• Phone: +8675525030234
• Email: sales5@szastec.com
• Phone: +8675525030234
• Email: sales5@szastec.com
• Phone: +8675525030234
• Email: sales5@szastec.com
• Phone: +8675525030234
• Email: sales5@szastec.com
• Phone: +8675525030234
• Email: sales5@szastec.com
• Phone: +8675525030234
• Email: sales5@szastec.com
• Phone: +8675525030234
• Email: sales5@szastec.com
• Phone: +8675525030234
• Email: sales5@szastec.com
• Phone: +8675525030234
• Email: sales5@szastec.com
• Phone: +8675525030234
• Email: sales5@szastec.com
• Phone: +8675525030234
• Email: sales5@szastec.com
• Phone: +8675525030234
• Email: sales5@szastec.com
• Phone: +8675525030234
• Email: sales5@szastec.com
• Phone: +8675525030234
• Email: sales5@szastec.com
• Phone: +8675525030234
• Email: sales5@szastec.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970890320431 [Primary]
GS1	16970890320438 [Package]; Contains: 06970890320431; Package: carton [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143268

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: 2024-08-12
• Device Publish Date: 2024-08-02

On-Brand Devices [AVCOO]

• 16970890320438: AS8019
• 06970890320424: AS9020
• 16970890320452: TENS:To be used for temporary relief of pain associated with sore and aching muscles in the shou
• 16970890320445: TENS:To be used for temporary relief of pain associated with sore and aching muscles in the shou