# K143430: SmartTENS

- Pathway: 510(k) (Abbreviated)
- Applicant: Easy Med Instrument Co., Ltd.
- Decided: May 29, 2015 after 179 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 K940301 (1994). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140168: Easystim TN28_Otc, Easymed Instruments Co., Ltd. (2014) Summary page 4.
- K120398: Witouch Pro, Hollywog, LLC (2012) Summary page 5.

## Most influential descendants
- K190009: Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) (2019), 0 descendants of its own

## Indications for use
This device is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.

Source page: https://510kreport.com/device/K143430
Methodology: https://510kreport.com/methodology