# K050921: Easystim NMS-28

- Pathway: 510(k) (Abbreviated)
- Applicant: Easy Med Instrument Co., Ltd.
- Decided: Dec 12, 2005 after 243 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: 3 generations back to K994266 (2000). 5 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040253: Easy Med TN-28 C, Easy Med Instrument Co., Ltd. (2004) Summary page 2.
- K023997: Tenscare Ultima NMS/Ems, Tenscare, Ltd. (2003) Summary page 2.

## Most influential descendants
- 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 stands for Transcutaneous Electrical Nerve Stimulation. This TENS system is used to provide symptomatic pain relief for chronic, acute or post operative pain PMS/EMS stands for Powered Muscles Stimulator/Electrical Muscles Stimulator. This PMS/EMS system is indicated for: * Relaxation of muscle spasm • Increasing local blood circulation * Muscle re-education *Prevention or retardation of disuse atrophy *Prevention of venous thrombosis of the calf muscles immediately after surgery •Maintaining or increasing range of motion

Source page: https://510kreport.com/device/K050921
Methodology: https://510kreport.com/methodology