TENKER

GUDID 16970890320223

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: 16970890320223
• NIH Device Record Key: b804a961-6dc2-4a1c-b6c7-8086305bd2e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TENKER
• Version Model Number: AS2080
• 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
• 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
• 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	06970890320226 [Primary]
GS1	16970890320223 [Package]; Contains: 06970890320226; Package: carton [30 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: 2024-09-06
• Device Publish Date: 2024-08-29

On-Brand Devices [TENKER]

• 16970890320223: TENS:To be used for temporary relief of pain associated with sore and aching muscles in the shou
• 16970890320216: TENS:To be used for temporary relief of pain associated with sore and aching muscles in the shou
• 16970890320131: TENS:To be used for temporary relief of pain associated with sore and aching muscles in the shou
• 16970890320612: TENS:To be used for temporary relief of pain associated with sore and aching muscles in the shou