Tenscare Kegelfit Pelvic Floor Exerciser K-KEGEL

GUDID 05033435132089

The Kegelfit is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscl

TENSCARE LIMITED

Perineal orifice incontinence-control electrical stimulation system

• Primary Device ID: 05033435132089
• NIH Device Record Key: 52a1f9a7-1c8b-4c5a-8af7-5e81d0228b9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tenscare Kegelfit Pelvic Floor Exerciser
• Version Model Number: KegelFit2
• Catalog Number: K-KEGEL
• 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

Customer Support Contacts

• Phone: 800 308 7390
• Email: compliance@tenscare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05033435132089 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-19
• Device Publish Date: 2018-06-18

Devices Manufactured by TENSCARE LIMITED

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