Easy@Home Adhesive Electrode Pads

GUDID 10810038636129

EASY HEALTHCARE CORPORATION

Interferential electrical stimulation system electrode

• Primary Device ID: 10810038636129
• NIH Device Record Key: b0233261-a82c-4d9a-a040-c641377e4374
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Adhesive Electrode Pads
• Version Model Number: ETP015B
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• 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: false
• Expiration Date: true
• 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	00810038636122 [Primary]
GS1	10810038636129 [Package]; Contains: 00810038636122; Package: [384 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132588

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: 2024-04-23
• Device Publish Date: 2024-04-15

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