# K023997: Tenscare Ultima NMS/Ems

- Pathway: 510(k) (Traditional)
- Applicant: Tenscare, Ltd.
- Decided: Mar 3, 2003 after 90 days
- Product code: IPF (Stimulator, Muscle, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K994266 (2000). 3 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020846: Ultima Tens XL-A1, Tenscare, Ltd. (2002) Summary page 1.
- K011543: Tens Care, Model XL-Y3, Tenscare, Ltd. (2001)

## Most influential descendants
- 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
TENS is used for the relief and management of symptomatic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post traumatic acute pain. The Ultima NMS/EMS is indicated for the following; Relaxation of muscle spasm Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Prevention of venous thrombosis of the calf muscles immediately after surgery Maintaining or increasing range of motion

Source page: https://510kreport.com/device/K023997
Methodology: https://510kreport.com/methodology