# K171397: Sienna Ultimate Wireless Amplifier

- Pathway: 510(k) (Traditional)
- Applicant: Ems Handels Gesellschaft M.B.H.
- Decided: Oct 6, 2017 after 148 days
- Product code: GWL (Amplifier, Physiological Signal)
- Device class: 2
- Regulation: 21 CFR 882.1835
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K001564 (2000). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103140: Nicolet Wireless Eeg, Carefusion 209, Inc. (2011) Summary page 4.

## Indications for use
The Sienna Ultimate EEG amplifier is intended to be used as a front end amplifier to acquire, store and transmit electrophysiological signals in a wired or wireless mode for the EMS Neurodiagnostic system.

Source page: https://510kreport.com/device/K171397
Methodology: https://510kreport.com/methodology