Unicare (K-UNICARE-USA)
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by TensCare Ltd
Identity
- Trade Name
- Unicare EUDAMEDTensCare FDA UDI
- Generic Name
- Perineal orifice incontinence-control electrical stimulation system, home-use FDA UDI
- Device Name
- Unicare EUDAMEDThe Unicare 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 Unicare 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. Additionally, the Unicare offers drug-free relief from period pain. FDA UDI
- Model / Reference
- K-UNICARE EUDAMEDUnicare FDA UDI
- Description
- The Unicare 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 Unicare 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. Additionally, the Unicare offers drug-free relief from period pain. FDA UDI
Identifiers
- Catalog Number
- K-UNICARE FDA UDI
- Primary DI / UDI-DI
- 05033435135646 EUDAMEDFDA UDI
- Basic UDI-DI
- 5033435K00130ZC EUDAMED
- FDA Product Code
- KPI FDA 510(k)FDA UDINUH 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 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 876.5320 FDA 510(k)
- Regulation Number
- 876.5320 FDA 510(k)FDA UDI882.5890 FDA UDI
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- Medical Purpose
- Unicare is a medical device designed to be used in the home healthcare environment to treat symptoms of urinary and/or faecal incontinence as well as symptoms of primary menstrual pain (dysmenorrhoea); and is suitable for use by all who can control the device and understand the instructions. The Unicare may also help to relieve the pain of secondary menstrual pain due to conditions such as endometriosis, fibroids or pelvic inflammatory disease. EUDAMED
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
The Unicare (K-UNICARE-USA) is an electrical, non-implantable stimulator designed for managing urinary incontinence. Classified as a Class II device under FDA regulations, it delivers controlled electrical impulses to stimulate pelvic floor muscles, aiding in the voluntary control of bladder function.
This device is supplied as a reusable, non-sterile medical instrument intended for use in clinical settings such as urology and gastroenterology. It is regulated under FDA 510(k) clearance and the EU Medical Device Regulation (MDR), with a registration number of 1718873 and associated FEI numbers. Storage and handling follow standard electrical medical device protocols, and its use is governed by regulatory compliance with 21 CFR 876.5320.
Frequently asked questions
What clinical specialties is the Unicare (K-UNICARE-USA) primarily used in, and how does it function?
The Unicare (K-UNICARE-USA) is primarily used in urology and gastroenterology specialties, as indicated by its advisory committee classification. It functions as an electrical, non-implantable stimulator designed to manage urinary incontinence by delivering controlled electrical impulses to stimulate pelvic floor muscles, helping patients regain voluntary bladder control.
Is the Unicare (K-UNICARE-USA) intended for single-use or reusable applications, and what are the storage requirements?
The Unicare (K-UNICARE-USA) is supplied as a reusable, non-sterile device, intended for use in clinical settings. Storage and handling follow standard protocols for electrical medical devices, ensuring compliance with regulatory guidelines (e.g., 21 CFR 876.5320). Since it is reusable, proper cleaning and maintenance per manufacturer instructions are essential to prevent contamination and ensure safe, prolonged use.
What regulatory pathways does the Unicare (K-UNICARE-USA) follow, and how does this affect its availability?
The Unicare (K-UNICARE-USA) has undergone FDA 510(k) clearance and complies with the EU Medical Device Regulation (MDR). Its classification as a Class II device under FDA regulations and the associated registration numbers (e.g., 1718873) confirm its regulatory status. This means it is legally marketable in the U.S. and EU, provided all compliance requirements are met, but clinicians should verify local regulatory adherence before use.
Does the Unicare (K-UNICARE-USA) come with multiple models or sizes, and if so, how are they differentiated?
The device data lists multiple FEI (Facility Equipment Identifier) numbers, which may correspond to different configurations, accessories, or variants of the Unicare (K-UNICARE-USA) system. However, the specifications do not explicitly detail size variations or model distinctions. Clinicians should consult the manufacturer’s documentation or contact TensCare Ltd (contact: Saskia Eldridge-Hinmers) for precise information on available models, as these identifiers typically relate to inventory or facility tracking rather than clinical specifications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K230983 | Class II | Active |
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Manufacturer
- Manufacturer
- TensCare Ltd
- FDA Applicant
- Tenscare, Ltd.
Sources (3)
- FDA 510(k) K230983 24 fields · synced Sep 18, 2026
- FDA UDI c502ec43-5661-4720-b906-57d070b27d09 35 fields · synced May 30, 2026
- EUDAMED e172e72e-27cc-4b3e-ae75-4e20f9cd03a9 61 fields · synced Jul 24, 2026