Easy@Home Self-Adhesive Reusable Electrodes

GUDID 10850253007786

EASY HEALTHCARE CORPORATION

Interferential electrical stimulation system electrode

• Primary Device ID: 10850253007786
• NIH Device Record Key: 8d9feb26-d6a7-46f8-bb5c-731d52c4128d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Self-Adhesive Reusable Electrodes
• Version Model Number: ETP101
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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	00850253007789 [Primary]
GS1	10850253007786 [Package]; Contains: 00850253007789; Package: Carton [96 Units]; In Commercial Distribution
GS1	30850253007780 [Unit of Use]

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: 2016-12-09

Devices Manufactured by EASY HEALTHCARE CORPORATION

• 10810038636846 - Easy@Home Pregnancy Test (5 tests): 2024-11-18 Easy@Home Pregnancy Test (5 tests)
• 10810038636266 - Easy@Home Blood Pressure Monitor: 2024-11-12
• 10810038636990 - Areta Multi-Drug Test Cup (25 tests kit): 2024-10-08 Areta 5 Panel Drug Test Cup (25 Test Kit) - THC,COC,OPI2000,BZO,AMP
• 10810038636549 - Easy@Home Pregnancy Test: 2024-10-04 Easy@Home Pregnancy Test
• 40810038636434 - Easy@Home Multi-Drug Screen Test (5 tests kit): 2024-07-25 5 tests kit;5-Panel Dip Card;AMP/BZO/COC/OPI/THC
• 20810038636447 - Easy@Home Nicotine Urine Test (5 tests one kit): 2024-07-25 5 tests kit; Nicotine Urine Test -COT
• 10810038636488 - Premom Smart Basal Thermometer: 2024-05-20
• 10810038636129 - Easy@Home Adhesive Electrode Pads: 2024-04-23