TEC.BEAN

GUDID 06970890328960

Shenzhen As-Tec Technology Co.,Ltd.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06970890328960
• NIH Device Record Key: 3db1f858-0fed-4bb2-afaf-9152ae381cfa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEC.BEAN
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970890320002 [Primary]
GS1	06970890328960 [Package]; Contains: 06970890320002; Package: Carton [32 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143268

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2017-08-29

On-Brand Devices [TEC.BEAN]

• 06970890329283: AS1080
• 06970890328960: AS1080
• 06970890328963: AS1080
• 16970890320209: TENS:To be used for temporary relief of pain associated with sore and aching muscles in the shou