# K233054: Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Well-Life Healthcare Limited
- Decided: Oct 18, 2024 after 389 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: 4 generations back to K130802 (2013). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172809: OTC Combo TENS/EMS System, Well-Life Healthcare Limited (2017) Summary page 5.
- K183110: LIVIA, Lifecare, Ltd. (2020) Summary page 6.

## Indications for use
For WL-2315C(M) and WL-2315E(M) models: The WL-2315C(M) and WL-2315E(M) are designed for the symptomatic relief and management of pain. They offer temporary relief from pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication. For WL-2405H(M) model: The WL-2405H(M) is designed for symptomatic relief and management of chronic pain and provides temporary relief from sore and aching muscles in the shoulders, waist, back, neck, upper extremities (arms), and lower extremities (legs) due to strain from exercise or daily activities. It also offers temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication. Additionally, the WL-2405H(M) features EMS functionality for stimulating healthy muscles to enhance or facilitate muscle performance (select EMS modes). It also provides symptomatic relief and management of chronic, intractable pain and relief from pain associated with arthritis (select TENS mode P8).

Source page: https://510kreport.com/device/K233054
Methodology: https://510kreport.com/methodology