Identity
- Trade Name
- Kegel Toner EUDAMEDTensCare FDA UDI
- Generic Name
- Perineal orifice incontinence-control electrical stimulation system FDA UDI
- Device Name
- Perfect PFE EUDAMEDThe Kegel Toner is a powered muscle stimulator used for strengthening the pelvic floor muscles. The Kegel Toner is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress incontinence in women. FDA UDI
- Model / Reference
- K-KT EUDAMEDKegel Toner FDA UDI
- Description
- The Kegel Toner is a powered muscle stimulator used for strengthening the pelvic floor muscles. The Kegel Toner is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress incontinence in women. FDA UDI
Identifiers
- Catalog Number
- K-KT FDA UDI
- Primary DI / UDI-DI
- 05033435134021 EUDAMEDFDA UDI
- Basic UDI-DI
- 5033435K00053ZK EUDAMED
- FDA Product Code
- KPI FDA UDI
- EMDN Code
- U070399 PELVIC FLOOR REHABILITATION DEVICES - OTHER EUDAMED
- GMDN Term
- Perineal orifice incontinence-control electrical stimulation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5320 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Kegel Toner by TensCare Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5033435K00053ZK | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- TensCare Ltd
- EUDAMED SRN
- GB-MF-000004156
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 87278c9f-c85c-4e28-907c-3053bc50b5ee 61 fields · synced Jul 19, 2026
- FDA UDI d5bbc753-8098-489b-af97-0a51287379bd 35 fields · synced May 30, 2026