# K151995: Painmaster MCT Patch

- Pathway: 510(k) (Traditional)
- Applicant: Newmark, Inc.
- Decided: Oct 5, 2016 after 443 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.
- K013167: MODEL7500 Microcurrent Tens Device, MCT-F5, MCT-F50, MCT-F500, Newcare Products, LLC (2002) Summary page 4.

## 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. • 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. • symptomatic relief of chronic, intractable pain.

Source page: https://510kreport.com/device/K151995
Methodology: https://510kreport.com/methodology