Easy@Home TENS and Powered Muscle Stimulator

GUDID 10810038634842

EASY HEALTHCARE CORPORATION

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• Primary Device ID: 10810038634842
• NIH Device Record Key: 27cbd597-c9e2-4f7a-8836-dac469ffeb2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home TENS and Powered Muscle Stimulator
• Version Model Number: EHE020
• 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	00810038634845 [Primary]
GS1	10810038634842 [Package]; Contains: 00810038634845; Package: [30 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: 2023-06-08
• Device Publish Date: 2023-05-31

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