# K912071: Space (TM) 7500

- Pathway: 510(k) (Traditional)
- Applicant: F.M. Wiest USA, Inc.
- Decided: Jul 9, 1991 after 60 days
- Product code: IKN (Electromyograph, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 890.1375
- 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. The FDA summary names no predicate by number.

## Most influential descendants
- K964522: Ellipse 4 (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K912071
Methodology: https://510kreport.com/methodology