# K123866: TANYX

- Pathway: 510(k) (Traditional)
- Applicant: Medecell Us, Inc.
- Decided: Sep 13, 2013 after 270 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 K940301 (1994). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 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 1.

## Most influential descendants
- K172451: Dr.MUSIC 3s (2017), 0 descendants of its own

## Indications for use
To be used in adults only for temporary relief of pain associated with sore and aching muscles in the upper extremities (arms), lower extremities (legs), and lower back due to strain from exercise or normal household and work activities.

Source page: https://510kreport.com/device/K123866
Methodology: https://510kreport.com/methodology
