# K010665: Transamerica Digital Ems

- Pathway: 510(k) (Special)
- Applicant: Transamerica Medical Systems
- Decided: Apr 27, 2001 after 52 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.
20 later devices descend from it; 1 cites it directly.
0 of 21 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
- K020750: Digital Electrical Muscle Stimulator, Model EV-807 Digital Ems (2002), 19 descendants of its own
- K071951: Comfy Series: EV-804, EV-805 & EV-806 (2007), 14 descendants of its own
- K082514: Tens/Ems Combo, Ems, Tens (2008), 6 descendants of its own
- K100117: LT3000 Combo Stimulator, LT3001 Tens Stimulatory, LT3002 Ems Stimulator (2010), 4 descendants of its own
- K112288: Jiajian Tens (2012), 3 descendants of its own

Source page: https://510kreport.com/device/K010665
Methodology: https://510kreport.com/methodology