# K172079: Avail

- Pathway: 510(k) (Traditional)
- Applicant: Omron Healthcare, Inc.
- Decided: Oct 19, 2017 after 101 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: 2 generations back to K130802 (2013). 2 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151035: PulseRelief, Philips Consumer Lifestyle (2015) Summary page 5.

## Most influential descendants
- K183215: Focus TENS Therapy, Model PM710-M/-L (2019), 1 descendant of its own
- K220997: Wireless TENS/EMS, Bruno, Aela (2022), 0 descendants of its own
- K191075: Healy (2019), 0 descendants of its own
- K182120: Maxpower Relief (2019), 0 descendants of its own
- K181992: Heat Pain Pro (2018), 0 descendants of its own

## Indications for use
The Avail is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, legs, shoulders or feet due to strain from exercise or normal household work activities. When used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, use the Tap, Shoulder, Arm or Leg mode of stimulation. Environments of Use: Clinics, hospital and home environments Patient Population: Adult

Source page: https://510kreport.com/device/K172079
Methodology: https://510kreport.com/methodology