Easy@Home Electronic TENS Pulse Massager

GUDID 00850253007130

EASY HEALTHCARE CORPORATION

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• Primary Device ID: 00850253007130
• NIH Device Record Key: 4b40bdc0-7c2e-4e7d-b0d7-db320d8b810e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Electronic TENS Pulse Massager
• Version Model Number: EHE010
• 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: false
• Serial Number: true
• 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	00850253007130 [Primary]
GS1	10850253007137 [Package]; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131921

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-26
• Device Publish Date: 2016-08-05

On-Brand Devices [Easy@Home Electronic TENS Pulse Massager]

• 10850253007755: EHE012PRO
• 00850253007130: EHE010
• 10810038630103: EHE012PRO