# K040253: Easy Med TN-28 C

- Pathway: 510(k) (Traditional)
- Applicant: Easy Med Instrument Co., Ltd.
- Decided: Apr 8, 2004 after 64 days
- Product code: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)
- 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: 1 generation back to K994266 (2000). 1 ancestor in all.
13 later devices descend from it; 4 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)
- K994266: Fdtens 2010, Fuji Dynamics Limited (2000) Summary page 1.

## Most influential descendants
- K140168: Easystim TN28_Otc (2014), 6 descendants of its own
- K050921: Easystim NMS-28 (2005), 3 descendants of its own
- K120054: Ultima Neo (2012), 2 descendants of its own
- K232441: Unipro (K-UNIPRO-US) (2024), 1 descendant of its own
- K183288: Transcutaneous Electrical Nerve Stimulator (2019), 1 descendant of its own

## Indications for use
T.E.N.S. stands for Transcutaneous Electrical Nerve Stimulation. This T.E.N.S. system is used to provide symptomatic pain relief for chronic, acute or post operative pain.

Source page: https://510kreport.com/device/K040253
Methodology: https://510kreport.com/methodology