# K150220: STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast

- Pathway: 510(k) (Traditional)
- Applicant: Eb Neuro S.P.A.
- Decided: Aug 19, 2015 after 201 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K905059 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061645: Magpro, Model R30, Tonica Elektronik A/S (2006) Summary page 4.

## Indications for use
The STM9000 is intended for stimulation of peripheral nerves for diagnostic purposes.

Source page: https://510kreport.com/device/K150220
Methodology: https://510kreport.com/methodology