# K171802: ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Healthcare, LLC
- Decided: Mar 7, 2018 after 261 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: 7 generations back to K912178 (1991). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152852: ALEVE Direct Therapy (ALEVE Direct Therapy TENS device), Bayer Healthcare, LLC (2015) Summary page 4.
- K131159: Smartrelief, Chattem, Inc. (2013) Summary page 4.

## Indications for use
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. For symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

Source page: https://510kreport.com/device/K171802
Methodology: https://510kreport.com/methodology