# K994266: Fdtens 2010

- Pathway: 510(k) (Traditional)
- Applicant: Fuji Dynamics Limited
- Decided: Jul 6, 2000 after 202 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
No predicates in its family tree.
20 later devices descend from it; 4 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K040253: Easy Med TN-28 C (2004), 13 descendants of its own
- K140168: Easystim TN28_Otc (2014), 6 descendants of its own
- K020846: Ultima Tens XL-A1 (2002), 5 descendants of its own
- K023997: Tenscare Ultima NMS/Ems (2003), 4 descendants of its own
- K050921: Easystim NMS-28 (2005), 3 descendants of its own

## Indications for use
TENS stands for Transcutaneous Electrical Nerve Stimulation and is a non-invasive and drug-free pain management unit. The TENS system is designed for the treatment of pain - chronic, acute or post-operative pain.

Source page: https://510kreport.com/device/K994266
Methodology: https://510kreport.com/methodology