Ova+ (K-OVAP-USA)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by TensCare Ltd
Identifiers
- 510(k) Number
- K230926 FDA 510(k)
- FDA Product Code
- NUH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5890 FDA 510(k)
- Regulation Number
- 882.5890 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ova+ (K-OVAP-USA) is a Transcutaneous Electrical Nerve Stimulator (TENS) device, classified under 21 CFR 882.5890. It is designed to deliver non-invasive electrical stimulation to superficial nerves via self-adhesive electrodes applied to intact skin, providing drug-free pain relief for conditions such as menstrual cramps. The device operates on a single-channel battery-powered system with preset treatment modes, enabling users to manage discomfort without medication. Its compact and wearable design allows for continuous use under clothing, supporting an active lifestyle.
The Ova+ is intended for home use and is supplied as a single-use or reusable device (as per manufacturer specifications). It is not classified as sterile and requires no special storage conditions beyond those recommended in the instructions for use. The device is FDA-cleared under a Traditional 510(k) pathway (K230926) and complies with MDR regulations. Electrode placement and treatment settings are manually controlled via push-buttons, with no MRI safety considerations specified. Sizes or additional technical specifications beyond the model code are not detailed in the regulatory data.
Frequently asked questions
What types of pain conditions is the Ova+ (K-OVAP-USA) specifically designed to address, and how does it work?
The Ova+ is designed to provide drug-free pain relief for menstrual cramps by delivering non-invasive electrical stimulation to superficial nerves via self-adhesive electrodes placed on intact skin. It uses a single-channel battery-powered system with preset treatment modes to help manage discomfort without medication, making it suitable for home use during periods of menstrual discomfort.
Is the Ova+ (K-OVAP-USA) intended for single-use or reusable applications, and how should it be stored?
The Ova+ can be supplied as either a single-use or reusable device, depending on the manufacturer’s specifications. Since it is not classified as sterile, no special storage conditions are required beyond those outlined in the instructions for use. Simply follow the provided guidelines to maintain its functionality.
How is the Ova+ (K-OVAP-USA) controlled, and are there any safety considerations for use, such as MRI compatibility?
The Ova+ is manually controlled via push-buttons, allowing users to adjust electrode placement and treatment settings. There are no explicit MRI safety considerations mentioned in the regulatory data, so users should avoid using it near MRI environments unless confirmed safe by the manufacturer. Always follow the device’s instructions for proper operation.
What regulatory pathways has the Ova+ (K-OVAP-USA) followed, and which advisory committee was involved in its review?
The Ova+ received FDA clearance through a Traditional 510(k) pathway (K230926) and is also compliant with MDR regulations. Its review was conducted by the Neurology (NE) Advisory Committee, which evaluates devices related to neurological conditions, including pain management solutions.
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. Sources consulted: TensCare Ova+ The Ova+ is a non-invasive small and… - FDA.report, Ova+ (K-OVAP-USA) (K230926) — FDA 510 (k) | Innolitics, TENSCARE OVA+ INSTRUCTIONS FOR USE MANUAL Pdf Download, PDF December 15, 2023 Saskia Eldridge-Hinmers Regulatory Affairs Associate ...
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 | K230926 | Class II | Active |
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Manufacturer
- Manufacturer
- TensCare Ltd
- FDA Applicant
- Tenscare, Ltd.
Sources (2)
- FDA 510(k) K230926 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 19, 2026