Neocontrol Pelvic Floor Therapy System, Incontinence Treatment Device

GUDID LT2061

The device is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic Hoor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women, helping with incontinence problems, Improve pelvic muscle strength. The device is supplied with a vaginally inserted electrodet,LCD Display,Comfortable treatment with 7 preset programs and intensity levels from 0 to 99.

BLISSCO MEDICAL DEVICE LIMITED

Perineal orifice incontinence-control electrical stimulation system, home-use

• Primary Device ID: LT2061
• NIH Device Record Key: 4fe35d2c-311d-4120-8b0a-b768eff6cfc2
• Commercial Distribution Discontinuation: 2025-04-04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neocontrol Pelvic Floor Therapy System, Incontinence Treatment Device
• Version Model Number: LT2061
• Company DUNS: 989184851
• Company Name: BLISSCO MEDICAL DEVICE 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	LT2061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001903

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: 2
• Public Version Date: 2024-11-25
• Device Publish Date: 2024-11-14

On-Brand Devices [Neocontrol Pelvic Floor Therapy System, Incontinence Treatment Device]

• LT2061: The device is intended to provide electrical stimulation and neuromuscular reeducation for the p
• G680LT2061: The device is intended to provide electrical stimulation and neuromuscular reeducation for the p