PowerDot

GUDID 04719872330622

Self-adhesive electrode package (with magnetic snap) , Blue, Each package contains electrode dia.55mm (2pcs) + 50mm*90mm (1pcs)

ZMI ELECTRONICS LTD.

Neuromuscular transmission electrode

• Primary Device ID: 04719872330622
• NIH Device Record Key: dcfecee6-a48e-440f-bade-cc2f99109fce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PowerDot
• Version Model Number: SAE-MC-PD-01MTBL
• Company DUNS: 657406062
• Company Name: ZMI ELECTRONICS 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

Customer Support Contacts

• Phone: +88678150053
• Email: mail@zmi-electronics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872330622 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180865

FDA Product Code

• GXY: Electrode, Cutaneous

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: 2019-12-18
• Device Publish Date: 2019-12-10

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• 04719872330325: PowerDot PD-01 Muscle Stimulator, Red (with PowerDot Mobile Application)
• 04719872330318: PowerDot PD-01 Muscle Stimulator, Black (with PowerDot Mobile Application)
• 04719872330639: Self-adhesive electrode, butterfly type
• 04719872330622: Self-adhesive electrode package (with magnetic snap) , Blue, Each package contains electrode d
• 04719872330615: PowerDot PD-01MT Muscle Stimulator, Blue
• 04719872330929: Self-adhesive electrode package (with magnetic snap) , American Flag , Each package contains e