Identity
- Trade Name
- iTouch Sure EUDAMEDTensCare FDA UDI
- Generic Name
- Perineal orifice incontinence-control electrical stimulation system, home-use FDA UDI
- Device Name
- iTouch Sure 2 EUDAMEDThe iTouch Sure 2 is a powered muscle stimulator used for strengthening the pelvic floor muscles. It sends a gentle stimulation (similar to your natural nerve impulses) direct to your pelvic floor muscles through a vaginal probe with stainless steel electrodes. These signals make your pelvic floor muscles contract. If you have forgotten how to contract them, are having trouble getting muscle response, or simply want to bring back the condition of your pelvic floor muscles, the itouch sure can work them for you to build up their strength and help you to develop your own muscle control. It perfectly complements pelvic floor exercises. The itouch sure is very easy to use, with four clearly labelled preset training programmes and a simple push button control. FDA UDI
- Model / Reference
- K-ITS EUDAMEDiTouch Sure FDA UDI
- Description
- The iTouch Sure 2 is a powered muscle stimulator used for strengthening the pelvic floor muscles. It sends a gentle stimulation (similar to your natural nerve impulses) direct to your pelvic floor muscles through a vaginal probe with stainless steel electrodes. These signals make your pelvic floor muscles contract. If you have forgotten how to contract them, are having trouble getting muscle response, or simply want to bring back the condition of your pelvic floor muscles, the itouch sure can work them for you to build up their strength and help you to develop your own muscle control. It perfectly complements pelvic floor exercises. The itouch sure is very easy to use, with four clearly labelled preset training programmes and a simple push button control. FDA UDI
Identifiers
- Catalog Number
- K-ITS FDA UDI
- Primary DI / UDI-DI
- 05033435070039 EUDAMEDFDA UDI
- Basic UDI-DI
- 5033435K00030Z7 EUDAMED
- 510(k) Number
- K103698 FDA UDI
- FDA Product Code
- KPI FDA UDI
- EMDN Code
- U070399 PELVIC FLOOR REHABILITATION DEVICES - OTHER EUDAMED
- GMDN Term
- Perineal orifice incontinence-control electrical stimulation system, home-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5320 FDA UDI
- Market of Registration
- Netherlands 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
iTouch Sure 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 | 5033435K00030Z7 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- TensCare Ltd
- EUDAMED SRN
- GB-MF-000004156
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED d6efd42b-f5e6-4404-8bdb-8e4a1b4fc3cb 61 fields · synced Jul 8, 2026
- FDA UDI e77b8383-d2c9-4cfc-bc12-6f6f89884a71 35 fields · synced May 30, 2026