Easy@Home Mini Wireless TENS Pulse Stimulator

GUDID 10810038633357

EASY HEALTHCARE CORPORATION

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• Primary Device ID: 10810038633357
• NIH Device Record Key: 5ad02fa6-9f89-4c68-afab-539b0d9f0992
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Mini Wireless TENS Pulse Stimulator
• Version Model Number: EHE015B
• 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	00810038633350 [Primary]
GS1	10810038633357 [Package]; Contains: 00810038633350; Package: [80 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: 2022-07-26
• Device Publish Date: 2022-07-18

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

• 10855944007427: EHE015
• 10810038630097: EHE015
• 10810038633357: EHE015B