MYOPUX

GUDID 00810093080144

MYOPUX eDN Xpansion White&Black

Hi-Dow International Incorporated

Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 00810093080144
• NIH Device Record Key: b160ef9c-754e-4a7d-8e63-484a1143bfd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MYOPUX
• Version Model Number: HD-5N-20A-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	00810093080144 [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: 2024-05-17
• Device Publish Date: 2024-05-09

On-Brand Devices [MYOPUX]

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