# K181992: Heat Pain Pro

- Pathway: 510(k) (Traditional)
- Applicant: Omron Healthcare, Inc.
- Decided: Nov 9, 2018 after 106 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). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160115: Heat Pain Pro, Omron Healthcare, Inc. (2016) Summary page 4.
- K172079: Avail, Omron Healthcare, Inc. (2017) Summary page 4.

## Indications for use
The Omron Heat Pain Pro Model PM311B is intended for: The relief of pain associated with sore or aching, muslces of the lower back, arm, legs, shoulder, or foot 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. Environment of Use: Clinics, hospital and home environments. Patient Population: Adult

Source page: https://510kreport.com/device/K181992
Methodology: https://510kreport.com/methodology