# K120500: The Pain Pilot (a.K.a Pain Pilot)

- Pathway: 510(k) (Traditional)
- Applicant: Hollywog, LLC
- Decided: Aug 20, 2012 after 181 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). 18 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110068: Model PM3030, Omron Healthcare, Inc. (2011) Summary page 2.
- K090042: Painmaster MCT Patch, Newmark, Inc. (2009) Summary page 2.
- K060846: Therapeutic Massage Companion, Endurance Therapeutics (2007) Summary page 2.

## Most influential descendants
- K152852: ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) (2015), 2 descendants of its own
- K190009: Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) (2019), 0 descendants of its own
- K171802: ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) (2018), 0 descendants of its own
- K133502: 5000Z Firefly System (2014), 0 descendants of its own

## Indications for use
The device is 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/K120500
Methodology: https://510kreport.com/methodology