# K140168: Easystim TN28_Otc

- Pathway: 510(k) (Traditional)
- Applicant: Easymed Instruments Co., Ltd.
- Decided: Aug 28, 2014 after 217 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). 8 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 15 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 4.
- K040253: Easy Med TN-28 C, Easy Med Instrument Co., Ltd. (2004) Summary page 5.

## Most influential descendants
- K183288: Transcutaneous Electrical Nerve Stimulator (2019), 1 descendant of its own
- K150043: Transcutaneous Electrical Nerve Stimulators (TENS) (2015), 1 descendant of its own
- K143430: SmartTENS (2015), 1 descendant of its own
- K222867: AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) (2022), 0 descendants of its own
- K200237: Transcutaneous Electronic Nerve Stimulator (2020), 0 descendants of its own

## Indications for use
EasyStim TN28_OTC 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/K140168
Methodology: https://510kreport.com/methodology