Home GUDID LT2061 Neocontrol Pelvic Floor Therapy System, Incontinence Treatment Device
Primary DI LT2061
Brand Neocontrol Pelvic Floor Therapy System, Incontinence Treatment Device
Company BLISSCO MEDICAL DEVICE LIMITED
Model LT2061
Device description 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.
Published 2024-11-14
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
Single use false Product Codes# Code, Name table Code Name KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KPI Stimulator, Electrical, Non-Implantable, For Incontinence Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status LT2061 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Perineal orifice incontinence-control electrical stimulation system, home-use A device or device assembly available for use by a patient/layperson outside a clinical setting designed to treat urinary and/or faecal incontinence through the intravaginal/intra-anal application of electrical stimuli to the muscles of the pelvic floor to induce Kegel-like contractions. It consists of an electrically-powered external pulse generator/biofeedback unit with controls (e.g., hand-held remote control) intended for wired or wireless connection to a cylinder-like probe with surface electrodes designed to be inserted into the vagina and/or anus; the probe may be included in the device assembly. This is a reusable device.
Regulatory Flags# DUNS number 989184851 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published G680TW147 Laser Hair Growth Cap 1.0 D549215 2024-12-16 G680D549215 GWODE Laser Hair Growth Cap 1.0 D549215 2024-11-16 G680LT2061 Neocontrol Pelvic Floor Therapy System, Incontinence Treatment Device LT2061 LT2061 2024-11-14 D549215 GWODE Laser Hair Growth Cap 1.0 2024-11-16
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06942808259034 Intrelief PFE EasyMed Instruments Co., Ltd. KPI 2026-05-05 04719872333104 Levina ZMI ELECTRONICS LTD. KPI 2026-04-14 04719872333593 Levina ZMI ELECTRONICS LTD. KPI 2026-04-14 04719872333616 Levina ZMI ELECTRONICS LTD. KPI 2026-04-14 04719872334033 Levina ZMI ELECTRONICS LTD. KPI 2026-04-14 03830054238138 QuantumStar, StarFormer FOTONA d.o.o. KPI 2025-06-12 05033435134403 TensCare TENSCARE LIMITED KPI 2024-11-18 G680LT2061 Neocontrol Pelvic Floor Therapy System, Incontinence Treatment Device BLISSCO MEDICAL DEVICE LIMITED KPI 2024-11-14 03830054237728 StarFormer FOTONA d.o.o. KPI 2024-07-30 00092237626047 Richmar EMG Pro Drive Devilbiss Healthcare KPI 2024-06-28 00092237626054 Richmar EMG Pro Drive Devilbiss Healthcare KPI 2024-06-28 06970935830482 KONMED Shenzhen Konmed Technology Co., Ltd. KPI 2024-03-05 06970935830499 KONMED Shenzhen Konmed Technology Co., Ltd. KPI 2024-03-05 06970935830642 KONMED Shenzhen Konmed Technology Co., Ltd. KPI 2024-03-05 06970935830659 KONMED Shenzhen Konmed Technology Co., Ltd. KPI 2024-03-05 06970935830666 KONMED Shenzhen Konmed Technology Co., Ltd. KPI 2024-03-05 06970935830673 KONMED Shenzhen Konmed Technology Co., Ltd. KPI 2024-03-05 06970935830680 KONMED Shenzhen Konmed Technology Co., Ltd. KPI 2024-03-05 06970935830697 KONMED Shenzhen Konmed Technology Co., Ltd. KPI 2024-03-05 05033435135646 TensCare TENSCARE LIMITED KPI 2023-10-24 04053815076711 MFG-05 Zimmer MedizinSysteme GmbH KPI 2023-10-16 00860000860000 Yarlap I Relevium Labs, Inc. KPI 2023-10-07 00860000860031 Yarlap II Relevium Labs, Inc. KPI 2023-10-07 05033435070039 TensCare TENSCARE LIMITED KPI 2023-08-31 04719871189108 iSTIM EVERYWAY MEDICAL INSTRUMENTS CO., LTD. KPI 2023-08-30 04719871184769 Lifecare EVERYWAY MEDICAL INSTRUMENTS CO., LTD. KPI 2023-08-25 04719871184776 Lifecare EVERYWAY MEDICAL INSTRUMENTS CO., LTD. KPI 2023-08-25 04719871184783 Lifecare EVERYWAY MEDICAL INSTRUMENTS CO., LTD. KPI 2023-08-25 04719871184790 Lifecare EVERYWAY MEDICAL INSTRUMENTS CO., LTD. KPI 2023-08-25 04719871184806 Lifecare EVERYWAY MEDICAL INSTRUMENTS CO., LTD. KPI 2023-08-25