MYOPUX

GUDID 00810093080205

MYOPUX Xpansion Pux Black

Hi-Dow International Incorporated

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 00810093080205
• NIH Device Record Key: f39833e2-c4e6-4518-90e1-2385652d21a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MYOPUX
• Version Model Number: HD-5N-H-RECEIVER
• Company DUNS: 124034476
• Company Name: Hi-Dow International Incorporated
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810093080205 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163393

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: 2024-07-11
• Device Publish Date: 2024-07-03

On-Brand Devices [MYOPUX]

• 00810093080144: MYOPUX eDN Xpansion White&Black
• 00810093080137: MYOPUX eDN White
• 00810093080205: MYOPUX Xpansion Pux Black