Vicsainteck

GUDID 06970890320363

Shenzhen As-Tec Technology Co.,Ltd.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06970890320363
• NIH Device Record Key: 9dfad65a-99b9-4904-87e6-f387e5998ac0
• Commercial Distribution Discontinuation: 2026-04-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vicsainteck
• Version Model Number: AS8012
• 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: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970890320363 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200727

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: 2024-04-11
• Device Publish Date: 2024-04-03

On-Brand Devices [Vicsainteck]

• 06970890320363: AS8012
• 06970890320356: AS8015-A21
• 06970890320349: AS2080
• 06970890320325: AS1080-A55
• 06970890320301: AS1080