# K020846: Ultima Tens XL-A1

- Pathway: 510(k) (Traditional)
- Applicant: Tenscare, Ltd.
- Decided: May 21, 2002 after 67 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.
5 later devices descend from it; 1 cites it directly.
0 of 7 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
- K023997: Tenscare Ultima NMS/Ems (2003), 4 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
- K252236: CP Relief Wand Rx - TENS/NMES (2025), 0 descendants of its own

## Indications for use
For the symptomatic relief of chronic intractable pain

Source page: https://510kreport.com/device/K020846
Methodology: https://510kreport.com/methodology