COPPER Fit

GUDID 00851640007573

Electronic Muscle Stimulater

Hi-Dow International Incorporated

Transcutaneous electrical stimulation electrode

• Primary Device ID: 00851640007573
• NIH Device Record Key: 8cfd0a86-b30f-4539-8bbe-158b91ddbd98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COPPER Fit
• Version Model Number: JQ-5C-07A
• 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	00851640007573 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102598

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: 2020-07-02
• Device Publish Date: 2020-06-24

Devices Manufactured by Hi-Dow International Incorporated

• 00810093080373 - HiDow: 2024-10-30 Universal Receiver
• 00810093080205 - MYOPUX: 2024-07-11 MYOPUX Xpansion Pux Black
• 00810093080045 - HiDow: 2024-05-17 Pro-Touch Wireless 6-12 Black & White
• 00810093080137 - MYOPUX: 2024-05-17 MYOPUX eDN White
• 00810093080144 - MYOPUX: 2024-05-17 MYOPUX eDN Xpansion White&Black
• 00081009308007 - TrueStim: 2023-10-06 Pulsed Electromagnetic Field Wrap, Black, lower limb wrap
• 00810093080014 - PainPod: 2022-05-24 TENS for pain relief
• 00851640007672 - HiDow: 2022-05-24 Wrap Accessory Electrode, AcuElbow Wrap