KONMED /K-fit/pelvifine

GUDID 06970935830017

Pelvic Health Device is one of a new breed of modern Neuromuscular Stimulators (STIM) developed with the aim of achieving optimum pelvic health for wo

Shenzhen Konmed Technology Co., Ltd.

Perineal orifice incontinence-control electrical stimulation system

• Primary Device ID: 06970935830017
• NIH Device Record Key: aaa555d9-d8bc-4a96-8194-058a5941e618
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KONMED /K-fit/pelvifine
• Version Model Number: KM518
• Company DUNS: 544436531
• Company Name: Shenzhen Konmed Technology Co., Ltd.
• 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: true
• 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	06970935830017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163288

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-24

Devices Manufactured by Shenzhen Konmed Technology Co., Ltd.

• 06970935830710 - Pelvifine: 2025-02-26
• 06970935830482 - KONMED: 2024-03-13 Incontinence probe Perineal orifice incontinence-control electrical stimulation system electrode
• 06970935830499 - KONMED: 2024-03-13 Incontinence probe Perineal orifice incontinence-control electrical stimulation system electrode
• 06970935830642 - KONMED: 2024-03-13 Incontinence probe Perineal orifice incontinence-control electrical stimulation system electrode
• 06970935830659 - KONMED: 2024-03-13 Incontinence probe Perineal orifice incontinence-control electrical stimulation system electrode
• 06970935830666 - KONMED: 2024-03-13 Incontinence probe Perineal orifice incontinence-control electrical stimulation system electrode
• 06970935830673 - KONMED: 2024-03-13 Incontinence probe Perineal orifice incontinence-control electrical stimulation system electrode
• 06970935830680 - KONMED: 2024-03-13 Incontinence probe Perineal orifice incontinence-control electrical stimulation system electrode