No Brand

GUDID 06970890321001

Shenzhen As-Tec Technology Co.,Ltd.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06970890321001
• NIH Device Record Key: 0027f7f0-b5b4-4a66-a47c-41b86a774158
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: No Brand
• Version Model Number: AS100B
• 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: true
• 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	06970890321001 [Primary]
GS1	16970890321008 [Package]; Package: [90 Units]; Discontinued: 2019-07-20; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172933

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-23
• Device Publish Date: 2019-07-23

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