# K230926: Ova+ (K-OVAP-USA)

- Pathway: 510(k) (Traditional)
- Applicant: Tenscare, Ltd.
- Decided: Dec 15, 2023 after 256 days
- Product code: NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K940301 (1994). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183110: LIVIA, Lifecare, Ltd. (2020) Summary page 6.
- K200694: Perfect EMS, Tenscare, Ltd. (2021) Summary page 6.

## Indications for use
For Mode 0, Ova+ is indicated for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication. For Modes 1, 2& 3 Ova+ is indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.

Source page: https://510kreport.com/device/K230926
Methodology: https://510kreport.com/methodology