Omega

GUDID 06971712729852

Hong Qiangxing (Shen Zhen) Electronics Limited

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06971712729852
• NIH Device Record Key: fd0c9401-09da-451d-9d32-41578046e432
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omega
• Version Model Number: TENS
• Company DUNS: 421286946
• Company Name: Hong Qiangxing (Shen Zhen) Electronics Limited
• Device Count: 36
• DM Exempt: true
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971712729845 [Primary]
GS1	06971712729852 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121719
• Premarket Notification: K201354

FDA Product Code

• GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief
• 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: 2022-02-21
• Device Publish Date: 2022-02-12

On-Brand Devices [Omega]

• 06971712729579: Electrode cable
• 06971712729548: Footpad
• 06971712729524: waist belt
• 06971712729500: Massage kneepads
• 06971712729487: Massage socks
• 06971712729463: Massage gloves
• 06971712729852: TENS
• 06971712729937: TENS
• 06971712729913: TENS
• 06971712721818: TENS
• 06971712724864: TENS
• 06971712725168: TENS