# K921668: Staodyn Tuwave

- Pathway: 510(k) (Traditional)
- Applicant: Staodyne, Inc.
- Decided: Aug 3, 1992 after 117 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
No predicates in its family tree.
57 later devices descend from it; 1 cites it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K050046: Rehabilicare IF 3 Wave Interferential Stimulator System, Model 7110S (2005), 56 descendants of its own
- K093324: Empi Continuum (2010), 26 descendants of its own
- K124016: Empi Phoenix (2013), 25 descendants of its own
- K153704: Strive (2016), 24 descendants of its own
- K123354: Revitive IX (2013), 19 descendants of its own

Source page: https://510kreport.com/device/K921668
Methodology: https://510kreport.com/methodology