# K090042: Painmaster MCT Patch

- Pathway: 510(k) (Traditional)
- Applicant: Newmark, Inc.
- Decided: May 6, 2009 after 120 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: 4 generations back to K912178 (1991). 12 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013167: MODEL7500 Microcurrent Tens Device, MCT-F5, MCT-F50, MCT-F500, Newcare Products, LLC (2002) Summary page 1.
- K033122: 5000Z System (Otc), Prizm Medical, Inc. (2004) Summary page 1.
- K060222: Low Back Pain Relief System /Models GM310PP,GM320PP,GM321PP, and GM330PP, Gemore Technology Co, Ltd. (2006) Summary page 1.

## Most influential descendants
- K130114: Painmaster MCT Patch (2013), 5 descendants of its own
- K120500: The Pain Pilot (a.K.a Pain Pilot) (2012), 4 descendants of its own
- K152852: ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) (2015), 2 descendants of its own
- K133789: Dolphin Neurostim Otc (2015), 1 descendant of its own
- K190009: Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) (2019), 0 descendants of its own

## Indications for use
The Painmaster MCT Patch is indicated for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

Source page: https://510kreport.com/device/K090042
Methodology: https://510kreport.com/methodology