TensCare E-TR50100

GUDID 05033435139156

TheCarbon Mesh Electrode pads 50X100 mm 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: 05033435139156
• NIH Device Record Key: 7de238ab-0957-4d1d-a94a-b413970bcb29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TensCare
• Version Model Number: Carbon Mesh Electrode pads 50X100 mm
• Catalog Number: E-TR50100
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	05033435139156 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132588

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: 2024-11-14
• Device Publish Date: 2024-11-06

On-Brand Devices [TensCare]

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• 05033435000647: The Circle Electrode pads 25mm dia, is a pack of 10 reusable electrodes, with an intended use fo
• 05033435000517: The Carbon Mesh Electrode pads 50x100mm, is a pack of 4 reusable electrodes, with an intended us
• 05033435000500: The Carbon Mesh Electrode pads 50x50 mm, is a pack of 4 reusable electrodes, with an intended us
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• 05033435134090: The Ova+ is a non-invasive small and convenient unit that can be worn under clothing to provide
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• 05033435136933: Form Duo is a variant of the Perfect EMS medical device and is identical to the Form unit but co
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• 05033435139156: TheCarbon Mesh Electrode pads 50X100 mm are a pack of 4 reusable electrodes, with an intended us
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