K230926
- 510(k) number
- K230926
- Device name
- Ova+ (K-OVAP-USA)
- Applicant
- Tenscare, Ltd. GB
- Product code
- NUH — Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Decision date
- 2023-12-15
- Date received
- 2023-04-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K230926.pdf
Official FDA record: K230926
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.