← Back to catalogue
Neocontrol Pelvic Floor Therapy System, Incontinence Treatment Device
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Neocontrol Pelvic Floor Therapy System, Incontinence Treatment Device FDA UDI
- Generic Name
- Perineal orifice incontinence-control electrical stimulation system, home-use FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- LT2061 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- LT2061 FDA UDI
- Primary DI / UDI-DI
- G680LT2061 FDA UDI
- 510(k) Number
- K001903 FDA UDI
- FDA Product Code
- KPI FDA UDI
- GMDN Term
- Perineal orifice incontinence-control electrical stimulation system, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5320 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Neocontrol Pelvic Floor Therapy System, Incontinence Treatment Device by Blissco Medical Device Limited — Class II — FDA UDI — listed in FDA GUDID
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Blissco Medical Device Limited
Sources (1)
- FDA UDI 4fe35d2c-311d-4120-8b0a-b768eff6cfc2 36 fields · synced May 30, 2026