# K151034: PainKARE

- Pathway: 510(k) (Traditional)
- Applicant: Triowave Technologies
- Decided: Nov 21, 2015 after 218 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 K912178 (1991). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090042: Painmaster MCT Patch, Newmark, Inc. (2009) Summary page 4.
- K130114: Painmaster MCT Patch, Newmark, Inc. (2013) Summary page 4.

## Indications for use
The PainKARE is indicatied for Temporary relief of pain of sore and aching muscles, joints, and tissues due to strain from exercise or normal household and work activities.

Source page: https://510kreport.com/device/K151034
Methodology: https://510kreport.com/methodology