Umitec

GUDID 06950940802384

Shenzhen Osto Technology Co.,Ltd.

Acupuncture electrical stimulation system

• Primary Device ID: 06950940802384
• NIH Device Record Key: ca8860d2-709f-4a7c-91a0-e96516404f82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Umitec
• Version Model Number: AST-805B
• 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	06950940802377 [Primary]
GS1	06950940802384 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213056

FDA Product Code

• OLP: Over-The-Counter Powered Light Based Laser For Acne

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: 2025-02-07
• Device Publish Date: 2025-01-30

Devices Manufactured by Shenzhen Osto Technology Co.,Ltd.

• 06950940802469 - N/A: 2025-02-24
• 06950940802407 - N/A: 2025-02-18
• 06950940802421 - LumaDoc: 2025-02-10
• 06950940802384 - Umitec: 2025-02-07
• 06950940802384 - Umitec: 2025-02-07
• 06950940802445 - N/A: 2025-02-07
• 06950940802360 - N/A: 2025-01-28
• 06950940802346 - SUMOT: 2024-12-31
• 06950940802278 - capillus: 2024-12-09