# K130114: Painmaster MCT Patch

- Pathway: 510(k) (Traditional)
- Applicant: Newmark, Inc.
- Decided: Apr 16, 2013 after 90 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: 5 generations back to K912178 (1991). 13 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 19 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 1.
- K033122: 5000Z System (Otc), Prizm Medical, Inc. (2004) Summary page 1.

## Most influential descendants
- K133789: Dolphin Neurostim Otc (2015), 1 descendant of its own
- K182671: Medi-Direct TENS Pen (2019), 0 descendants of its own
- K182267: PAT (Pain Alleviation Technologies) (2019), 0 descendants of its own
- K151995: Painmaster MCT Patch (2016), 0 descendants of its own
- K151034: PainKARE (2015), 0 descendants of its own

## Indications for use
The Painmaster MOT Patch is indicated for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

Source page: https://510kreport.com/device/K130114
Methodology: https://510kreport.com/methodology