OHUHU

GUDID 06970890320493

used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back,neck,upper extremities(arm), and lower extremities( leg), due to strain from exercise or normal household and work activities.

Shenzhen As-Tec Technology Co.,Ltd.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06970890320493
• NIH Device Record Key: 3a71a3ca-7b6e-4f41-a0ee-4db5d999a990
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OHUHU
• Version Model Number: AS1080
• 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: true
• Expiration Date: false
• 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	06970890320493 [Primary]
GS1	16970890320490 [Package]; Package: carton [20 Units]; Discontinued: 2024-08-28; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200727

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: 2024-09-05
• Device Publish Date: 2024-08-28

Devices Manufactured by Shenzhen As-Tec Technology Co.,Ltd.

• 16970890320636 - AUVON: 2024-11-01 TENS:To be used for temporary relief of pain associated with sore and aching muscles in the shoulder,waist,back,upper extremitie
• 16970890320643 - AUVON: 2024-11-01 TENS:To be used for temporary relief of pain associated with sore and aching muscles in the shoulder,waist,back,upper extremitie
• 06970890320622 - NO: 2024-10-28
• 16970890320612 - TENKER: 2024-10-07 TENS:To be used for temporary relief of pain associated with sore and aching muscles in the shoulder,waist,back,upper extremitie
• 16970890320599 - Itouch relief: 2024-10-04 TENS:To be used for temporary relief of pain associated with sore and aching muscles in the shoulder,waist,back,upper extremitie
• 16970890320230 - eMP10: 2024-09-23 TENS:To be used for temporary relief of pain associated with sore and aching muscles in the shoulder,waist,back,upper extremitie
• 16970890320247 - eMP10: 2024-09-23 TENS:To be used for temporary relief of pain associated with sore and aching muscles in the shoulder,waist,back,upper extremitie
• 16970890320582 - No Brand: 2024-09-23 TENS:To be used for temporary relief of pain associated with sore and aching muscles in the shoulder,waist,back,upper extremitie