N/A

GUDID 06950940801899

Shenzhen Osto Technology Co.,Ltd.

Acupuncture electrical stimulation system Acupuncture electrical stimulation system Acupuncture electrical stimulation system Acupuncture electrical stimulation system Acupuncture electrical stimulation system Acupuncture electrical stimulation system Acupuncture electrical stimulation system Acupuncture electrical stimulation system Acupuncture electrical stimulation system Acupuncture electrical stimulation system Acupuncture electrical stimulation system Acupuncture electrical stimulation system Acupuncture electrical stimulation system Acupuncture electrical stimulation system Acupuncture electrical stimulation system Acupuncture electrical stimulation system Acupuncture electrical stimulation system

• Primary Device ID: 06950940801899
• NIH Device Record Key: dfbec0b1-b8aa-4c50-a5dc-93bc3c9d069d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: AST-2012A
• Company DUNS: 528161684
• Company Name: Shenzhen Osto Technology Co.,Ltd.
• Device Count: 1000
• 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: true
• 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	06950940801882 [Primary]
GS1	06950940801899 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172834

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: 2023-10-09
• Device Publish Date: 2023-09-30

On-Brand Devices [N/A]

• 06950940801646: AST-905D
• 06950940801639: AST-905B
• 06950940801899: AST-2012A
• 06950940801875: AST-300L
• 06950940801936: AST-603