EmbaGYN K-EMBAGYN

GUDID 05033435132171

EmbaGYN Pelvic Floor Exerciser is a portable, battery operated electrical muscle stimulator. EmbaGYN is indicated for the rehabilitation and strengthe

TENSCARE LIMITED

Perineal orifice incontinence-control electrical stimulation system

• Primary Device ID: 05033435132171
• NIH Device Record Key: 5a5e9dee-e75a-457f-a8d3-d661e96dba8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EmbaGYN
• Version Model Number: itouch Sure
• Catalog Number: K-EMBAGYN
• Company DUNS: 569403736
• Company Name: TENSCARE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05033435132171 [Primary]

FDA Product Code

• KPI: Stimulator, Electrical, Non-Implantable, For Incontinence

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-02-15

Devices Manufactured by TENSCARE LIMITED

• 05033435134403 - TensCare: 2024-11-26 The Kegelfit is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of w
• 05033435138777 - TensCare: 2024-11-14 The Cool Relief Electrode pads 50x50 mm are a pack of 4 reusable electrodes, with an intended use for the desired success of any
• 05033435138784 - TensCare: 2024-11-14 The Cool Relief Electrode pads 50x100 mm are a pack of 4 reusable electrodes, with an intended use for the desired success of an
• 05033435139118 - TensCare: 2024-11-14 The Hypoallergenic Electrode pads 50x50 mm are a pack of 4 reusable electrodes, with an intended use for the desired success of
• 05033435139132 - TensCare: 2024-11-14 The Carbon Mesh Electrode pads 50X50 mm are a pack of 4 reusable electrodes, with an intended use for the desired success of any
• 05033435139156 - TensCare: 2024-11-14 TheCarbon Mesh Electrode pads 50X100 mm are a pack of 4 reusable electrodes, with an intended use for the desired success of any
• 05033435139705 - TensCare: 2024-11-14 The Back Electrode is a reusable electrodes, with an intended use for the desired success of any stimulation (TENS or EMS). They
• 05033435139712 - TensCare: 2024-11-14 The Knee Electrode is a pack of 2 reusable electrodes, with an intended use for the desired success of any stimulation (TENS or