Elitone

GUDID 00851096008018

Muscle stimulator for the treatment of stress urinary incontinence

ELIDAH, INC.

Perineal orifice incontinence-control electrical stimulation system electrode

• Primary Device ID: 00851096008018
• NIH Device Record Key: d3a2d4fd-c395-4783-b4f8-476d1a63adc3
• Commercial Distribution Discontinuation: 2019-04-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Elitone
• Version Model Number: EK-1006
• Company DUNS: 079300140
• Company Name: ELIDAH, INC.
• 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: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851096008018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183585

FDA Product Code

• QAJ: Cutaneous Electrode Stimulator For Urinary 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: 2019-04-09
• Device Publish Date: 2019-04-01

On-Brand Devices [Elitone]

• 00851096008018: Muscle stimulator for the treatment of stress urinary incontinence
• 00851096008001: Elitone GelPads are transcutaneous electrodes to be used with the Elitone Device.
• 00851096008025: ELITONE GelPads are transcutaneous electrodes to be used with the ELITONE Device.
• 00851096008056: Elitone Incontinence Therapy Kit, includes 1x Elitone Device (00851096008018) and 2x Elitone Gel