Easy@Home Mini Electronic Pulse Stimulator

GUDID 10855944007908

EASY HEALTHCARE CORPORATION

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• Primary Device ID: 10855944007908
• NIH Device Record Key: 59b79ad0-8bb3-4564-a086-dbfc0060ad37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Mini Electronic Pulse Stimulator
• Version Model Number: EHE029N
• 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: true
• 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	00855944007901 [Primary]
GS1	10855944007908 [Package]; Contains: 00855944007901; Package: Carton [36 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143268

FDA Product Code

• NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter

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: 2019-06-28
• Device Publish Date: 2019-06-20

On-Brand Devices [Easy@Home Mini Electronic Pulse Stimulator]

• 00850253007147: EHE029G
• 10855944007908: EHE029N
• 10810038630257: EHE029N
• 10810038630165: EHE029G