# K230443: TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)

- Pathway: 510(k) (Traditional)
- Applicant: Jiangxi Royall Smart Technology Co., Ltd.
- Decided: May 22, 2023 after 90 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: 7 generations back to K940301 (1994). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163611: Pain Therapy Device, Guangzhou Xinbo Electronic Co., Ltd. (2017) Summary page 5.

## Indications for use
TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04): - To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. - To stimulate healthy muscles in order to improve and facilitate muscle performance . - To temporarily increase local blood circulation in healthy muscles.

Source page: https://510kreport.com/device/K230443
Methodology: https://510kreport.com/methodology