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
CodeName
KPIStimulator, Electrical, Non-Implantable, For Incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPIStimulator, Electrical, Non-Implantable, For IncontinenceGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001903000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001903000NEOCONTROL PELVIC FLOOR THERAPY SYSTEMNeotonus, Inc.2000-08-29KPI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
LT2061PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Perineal orifice incontinence-control electrical stimulation system, home-useA 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.

Sterilization Methods#

Method table
Method

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 DIBrandModelCatalogPublished
G680TW147Laser Hair Growth Cap1.0D5492152024-12-16
G680D549215GWODE Laser Hair Growth Cap1.0D5492152024-11-16
G680LT2061Neocontrol Pelvic Floor Therapy System, Incontinence Treatment DeviceLT2061LT20612024-11-14
D549215GWODE Laser Hair Growth Cap1.02024-11-16

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04719872334033LevinaZMI ELECTRONICS LTD.KPI2026-04-14
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05033435134403TensCareTENSCARE LIMITEDKPI2024-11-18
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