# K152852: ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Healthcare, LLC
- Decided: Dec 22, 2015 after 84 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). 19 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120500: The Pain Pilot (a.K.a Pain Pilot), Hollywog, LLC (2012) Summary page 4.

## Most influential descendants
- 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

## Indications for use
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/K152852
Methodology: https://510kreport.com/methodology