# K011543: Tens Care, Model XL-Y3

- Pathway: 510(k) (Traditional)
- Applicant: Tenscare, Ltd.
- Decided: Aug 31, 2001 after 105 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K011543
Methodology: https://510kreport.com/methodology