AUVON

GUDID 16970890320391

TENS:To be used for temporary relief of pain associated with sore and aching muscles in the shoulder,waist,back,upper extremities(arm),and lower extremities(leg)due to strain from exercise or normal household work activities. PMS:It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Shenzhen As-Tec Technology Co.,Ltd.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 16970890320391
• NIH Device Record Key: be8c2713-3093-46da-9cb9-4db2ef3cfca7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUVON
• Version Model Number: AS1080
• 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: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970890320394 [Primary]
GS1	16970890320391 [Package]; Contains: 06970890320394; 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: 2024-09-12
• Device Publish Date: 2024-09-04

On-Brand Devices [AUVON]

• 16970890320469: TENS:To be used for temporary relief of pain associated with sore and aching muscles in the shou
• 16970890320407: TENS:To be used for temporary relief of pain associated with sore and aching muscles in the shou
• 16970890320391: TENS:To be used for temporary relief of pain associated with sore and aching muscles in the shou
• 16970890320575: TENS:To be used for temporary relief of pain associated with sore and aching muscles in the shou
• 16970890320568: TENS:To be used for temporary relief of pain associated with sore and aching muscles in the shou
• 16970890320551: TENS:To be used for temporary relief of pain associated with sore and aching muscles in the shou
• 16970890320643: TENS:To be used for temporary relief of pain associated with sore and aching muscles in the shou
• 16970890320636: TENS:To be used for temporary relief of pain associated with sore and aching muscles in the shou