# K160115: Heat Pain Pro

- Pathway: 510(k) (Traditional)
- Applicant: Omron Healthcare, Inc.
- Decided: Jun 3, 2016 after 136 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: 6 generations back to K940301 (1994). 9 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141978: Maxpower Relief, Omron Healthcare, Inc. (2014) Summary page 4.

## Most influential descendants
- K190783: Health Expert Electronic Stimulator (model: AST-300L) (2020), 6 descendants of its own
- K211942: Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) (2021), 1 descendant of its own
- K210756: Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H (2021), 1 descendant of its own
- K223428: Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A) (2023), 0 descendants of its own
- K221092: Transcutaneous Electrical Nerve Stimulator Model: ST-304 (2022), 0 descendants of its own

## Indications for use
The Omron Heat Pain Pro is intended for: The relief of pain associated with sore or aching, muscles of the lower back, arms, legs, shoulder, or foot due to strain from exercise or normal household work activities. Environments of Use: Clinics, hospital and home environments Patient Population: Adult

Source page: https://510kreport.com/device/K160115
Methodology: https://510kreport.com/methodology