TensCare E00005

GUDID 05033435133185

The Face electrode pads are a pack of 4 reusable electrodes, with an intended use for the desired success of any stimulation (TENS or EMS). They are intended for a single user.

TENSCARE LIMITED

Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 05033435133185
• NIH Device Record Key: 7cdfdf3a-4a65-40cf-857e-121d03563159
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TensCare
• Version Model Number: Face Electrode pads
• Catalog Number: E00005
• Company DUNS: 569403736
• Company Name: TENSCARE LIMITED
• 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: false
• 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	05033435133185 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210448

FDA Product Code

• GXY: Electrode, Cutaneous

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: 2022-11-21
• Device Publish Date: 2022-11-11

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