# K183215: Focus TENS Therapy, Model PM710-M/-L

- Pathway: 510(k) (Traditional)
- Applicant: Omron Healthcare, Inc.
- Decided: Sep 7, 2019 after 292 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: 3 generations back to K130802 (2013). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172079: Avail, Omron Healthcare, Inc. (2017) Summary page 5.

## Most influential descendants
- K220997: Wireless TENS/EMS, Bruno, Aela (2022), 0 descendants of its own

## Indications for use
The device is intended for the relief of pain associated with sore or aching muscles of the lower extremities (leg) due to strain from exercise or normal household work activities. It is also intended for the use of symptomatic relief and management of chronic, intractable pain associated with arthritis. Environments of Use: Clinics, hospital and home environments Patient Population: Adult

Source page: https://510kreport.com/device/K183215
Methodology: https://510kreport.com/methodology