KONMED /Pelvifine

GUDID 06970935830581

This Biofeedback device is a type of biofeedback and neuromuscular electrical stimulation therapy device for patients with pelvic floor muscle dysfunction through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment.The device is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.

Shenzhen Konmed Technology Co., Ltd.

Perineal orifice incontinence-control electrical stimulator, home-use

• Primary Device ID: 06970935830581
• NIH Device Record Key: 086b8d47-3767-41b0-892b-ed48977756b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KONMED /Pelvifine
• Version Model Number: KM536
• Company DUNS: 544436531
• Company Name: Shenzhen Konmed Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	06970935830581 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220161

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: 2022-09-01
• Device Publish Date: 2022-08-24

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