Easy@Home Mini Wireless TENS Pulse Stimulator Replacement Pads

GUDID 00855944007659

EASY HEALTHCARE CORPORATION

Neuromuscular transmission electrode

• Primary Device ID: 00855944007659
• NIH Device Record Key: d97d5f3f-49c4-4e6b-9db9-75dc2ae4a27c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Mini Wireless TENS Pulse Stimulator Replacement Pads
• Version Model Number: ETP015
• 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	00855944007659 [Primary]
GS1	10855944007656 [Package]; Package: Carton [30 Units]; In Commercial Distribution
GS1	90855944007652 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141260

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: 2019-08-08
• Device Publish Date: 2019-07-31

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

• 10810038630080: ETP015
• 00855944007659: ETP015