KONMED /Pelvifine

GUDID 06970935830536

This Biofeedback Nerve and Muscle Stimulator is a new type of biofeedback and neuromuscular electrical stimulation therapy device through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment.

Shenzhen Konmed Technology Co., Ltd.

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• Primary Device ID: 06970935830536
• NIH Device Record Key: 59c5f98f-1f67-4104-bbdf-400111326782
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KONMED /Pelvifine
• Version Model Number: KM530
• Company DUNS: 544436531
• Company Name: Shenzhen Konmed Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: true
• 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	06970935830536 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202648

FDA Product Code

• IPF: Stimulator, Muscle, Powered

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: 2021-11-02
• Device Publish Date: 2021-10-25

On-Brand Devices [KONMED /Pelvifine]

• 06970935830543: This Biofeedback Nerve and Muscle Stimulator is a new type of biofeedback and neuromuscular elec
• 06970935830536: This Biofeedback Nerve and Muscle Stimulator is a new type of biofeedback and neuromuscular elec
• 06970935830598: This Biofeedback device is a type of biofeedback and neuromuscular electrical stimulation therap
• 06970935830581: This Biofeedback device is a type of biofeedback and neuromuscular electrical stimulation therap
• 06970935830574: This Biofeedback device is a type of biofeedback and neuromuscular electrical stimulation therap
• 06970935830567: This Biofeedback device is a type of biofeedback and neuromuscular electrical stimulation therap