NORTH AMERICAN Health+Wellness

GUDID 06950940801226

Shenzhen Osto Technology Co.,Ltd.

Acupuncture electrical stimulation system

• Primary Device ID: 06950940801226
• NIH Device Record Key: 127fa5fb-5530-4495-912f-dacdbbb4f1ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NORTH AMERICAN Health+Wellness
• Version Model Number: AST-300J
• Company DUNS: 528161684
• Company Name: Shenzhen Osto Technology Co.,Ltd.
• Device Count: 1612
• 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	06950940801219 [Primary]
GS1	06950940801226 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190673

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: 2020-04-28
• Device Publish Date: 2020-04-20

Devices Manufactured by Shenzhen Osto Technology Co.,Ltd.

• 06950940801967 - OSTO: 2024-04-10
• 06950940801981 - Creliver: 2024-04-08
• 06950940801936 - N/A: 2023-10-31
• 06950940801875 - N/A: 2023-10-30
• 06950940801899 - N/A: 2023-10-09
• 06950940801912 - MDIBZCA: 2023-10-09
• 06950940801783 - Auxoliev: 2023-05-09
• 06950940801769 - Creliver: 2023-04-10