# K220997: Wireless TENS/EMS, Bruno, Aela

- Pathway: 510(k) (Traditional)
- Applicant: Zmi Elecronics, Ltd.
- Decided: Sep 1, 2022 after 150 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161453: WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A, Well-Life Healthcare Limited (2016) Summary page 4.
- K183215: Focus TENS Therapy, Model PM710-M/-L, Omron Healthcare, Inc. (2019) Summary page 4.
- K183110: LIVIA, Lifecare, Ltd. (2020) Summary page 5.

## Indications for use
TENS: [RS-18, RS-28, RS-38 models]: 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. [RS-18, RS-38 models]: For temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medications. [RS-18, RS-28 models]: It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. EMS: [RS-18, RS-28 models]: To stimulate healthy muscles in order to improve and facilitate muscle performance. Environments of Use: Clinics, hospital and home environments (over-the-counter) Patient Population: Adult

Source page: https://510kreport.com/device/K220997
Methodology: https://510kreport.com/methodology