# K926410: Ultratone 8+ & 20

- Pathway: 510(k) (Traditional)
- Applicant: Bowater Research, Inc.
- Decided: Aug 11, 1993 after 233 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K102524: Futura (2011), 1 descendant of its own
- K233099: Gladiator (2024), 0 descendants of its own
- K041390: Diamond Medistim (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K926410
Methodology: https://510kreport.com/methodology