# K041063: Smartwave MS 2000

- Pathway: 510(k) (Traditional)
- Applicant: Newwave Medical, LLC
- Decided: Dec 1, 2004 after 222 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: 1 generation back to K926510 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926510: Staodyn Ems+2, Staodyne, Inc. (1993) Summary page 2.

## Most influential descendants
- K121305: Sterling Medical Impulse 3 Stimulator (2012), 0 descendants of its own

## Indications for use
1. Relaxation of muscle spasms 2. Prevention or retardation of disuse atrophy 3. Increasing local blood circulation 4. Muscle re-education 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis 6. Maintaining or increasing range of motion

Source page: https://510kreport.com/device/K041063
Methodology: https://510kreport.com/methodology