N/A

GUDID 06950940801646

Shenzhen Osto Technology Co.,Ltd.

Acupuncture electrical stimulation system

• Primary Device ID: 06950940801646
• NIH Device Record Key: 8c5b1d16-3ab3-4d42-b351-ec953ebd649c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: AST-905D
• Company DUNS: 528161684
• Company Name: Shenzhen Osto Technology Co.,Ltd.
• Device Count: 250
• 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	06950940801622 [Primary]
GS1	06950940801646 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210756

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: 2022-04-04
• Device Publish Date: 2022-03-26

On-Brand Devices [N/A]

• 06950940801646: AST-905D
• 06950940801639: AST-905B
• 06950940801899: AST-2012A
• 06950940801875: AST-300L
• 06950940801936: AST-603
• 06950940802032: AST-2012A
• 06950940802094: AST-300W
• 06950940802070: AST-300V
• 06950940802216: AST-300J