Easy@Home Heat TENS unit with Replacement Pads

GUDID 10855944007663

EASY HEALTHCARE CORPORATION

Electric pad localized-body heating system

• Primary Device ID: 10855944007663
• NIH Device Record Key: 9b4e69ac-b07c-4f04-bee3-54bafc457000
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Heat TENS unit with Replacement Pads
• Version Model Number: ETP018
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 2
• 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	00855944007666 [Primary]
GS1	10855944007663 [Package]; Contains: 00855944007666; Package: Carton [400 Units]; In Commercial Distribution
GS1	90855944007669 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162517

FDA Product Code

• IRT: Pad, Heating, Powered

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: 2019-08-09
• Device Publish Date: 2019-08-01

On-Brand Devices [Easy@Home Heat TENS unit with Replacement Pads]

• 10855944007663: ETP018
• 10810038631544: ETP018