Easy@Home Adhesive Electrodes

GUDID 00850253007161

EASY HEALTHCARE CORPORATION

Interferential electrical stimulation system electrode

• Primary Device ID: 00850253007161
• NIH Device Record Key: a5e7f583-23da-4011-a8c0-cf238df8df98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Adhesive Electrodes
• Version Model Number: ETP505
• 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850253007161 [Primary]
GS1	00850253007222 [Package]; Package: [4 Units]; In Commercial Distribution
GS1	10850253007229 [Package]; Contains: 00850253007222; Package: [125 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-26
• Device Publish Date: 2016-08-05

On-Brand Devices [Easy@Home Adhesive Electrodes]

• 00850253007178: ETP538
• 00850253007161: ETP505
• 00810038630052: ETP538
• 00810038630038: ETP505