# K912642: EMS300, EMS400, EMS8000

- Pathway: 510(k) (Traditional)
- Applicant: Skylark Device Co., Ltd.
- Decided: Dec 9, 1991 after 178 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K034005: SDS-4I (2004), 0 descendants of its own

Source page: https://510kreport.com/device/K912642
Methodology: https://510kreport.com/methodology