No Brand

GUDID 16970890320582

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: 16970890320582
• NIH Device Record Key: 78898af6-3db5-4893-94b5-c93f50c37f22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: No Brand
• Version Model Number: AS9034
• 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: +86075525030234
• Email: astec07@foxmail.com
• Phone: +86075525030234
• Email: astec07@foxmail.com
• Phone: +86075525030234
• Email: astec07@foxmail.com
• Phone: +86075525030234
• Email: astec07@foxmail.com
• Phone: +86075525030234
• Email: astec07@foxmail.com
• Phone: +86075525030234
• Email: astec07@foxmail.com
• Phone: +86075525030234
• Email: astec07@foxmail.com
• Phone: +86075525030234
• Email: astec07@foxmail.com
• Phone: +86075525030234
• Email: astec07@foxmail.com
• Phone: +86075525030234
• Email: astec07@foxmail.com
• Phone: +86075525030234
• Email: astec07@foxmail.com
• Phone: +86075525030234
• Email: astec07@foxmail.com
• Phone: +86075525030234
• Email: astec07@foxmail.com
• Phone: +86075525030234
• Email: astec07@foxmail.com
• Phone: +86075525030234
• Email: astec07@foxmail.com
• Phone: +86075525030234
• Email: astec07@foxmail.com
• Phone: +86075525030234
• Email: astec07@foxmail.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970890320585 [Primary]
GS1	16970890320582 [Package]; Contains: 06970890320585; Package: Carton [36 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-23
• Device Publish Date: 2024-09-14

On-Brand Devices [No Brand]

• 06970890321001: AS100B
• 16970890320582: TENS:To be used for temporary relief of pain associated with sore and aching muscles in the shou