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

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