Kongzee

GUDID 16970890320476

Shenzhen As-Tec Technology Co.,Ltd.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 16970890320476
• NIH Device Record Key: 547a0c5a-43ad-403f-9b49-1be7427a6283
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kongzee
• Version Model Number: AS9026
• 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	06970890320479 [Primary]
GS1	16970890320476 [Package]; Contains: 06970890320479; Package: Carton [40 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: 2024-08-12
• Device Publish Date: 2024-08-03

Devices Manufactured by Shenzhen As-Tec Technology Co.,Ltd.

• 16970890320636 - AUVON: 2024-11-01 TENS:To be used for temporary relief of pain associated with sore and aching muscles in the shoulder,waist,back,upper extremitie
• 16970890320643 - AUVON: 2024-11-01 TENS:To be used for temporary relief of pain associated with sore and aching muscles in the shoulder,waist,back,upper extremitie
• 06970890320622 - NO: 2024-10-28
• 16970890320612 - TENKER: 2024-10-07 TENS:To be used for temporary relief of pain associated with sore and aching muscles in the shoulder,waist,back,upper extremitie
• 16970890320599 - Itouch relief: 2024-10-04 TENS:To be used for temporary relief of pain associated with sore and aching muscles in the shoulder,waist,back,upper extremitie
• 16970890320230 - eMP10: 2024-09-23 TENS:To be used for temporary relief of pain associated with sore and aching muscles in the shoulder,waist,back,upper extremitie
• 16970890320247 - eMP10: 2024-09-23 TENS:To be used for temporary relief of pain associated with sore and aching muscles in the shoulder,waist,back,upper extremitie
• 16970890320582 - No Brand: 2024-09-23 TENS:To be used for temporary relief of pain associated with sore and aching muscles in the shoulder,waist,back,upper extremitie