# K171124: Nihon Kohden Wireless Input Unit WEE-1200

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden Corporation
- Decided: Aug 25, 2017 after 130 days
- Product code: GWQ (Full-Montage Standard Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K944678 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033475: Wireless Input Unit, Model Wee-1000A Series, Nihon Kohden America, Inc. (2004) Summary page 4.
- K113117: Nihon Kohden Eeg-1200A with JE-120A Multi Channel Electrode Junction Box, Nihon Kohden America, Inc. (2012) Summary page 4.

## Indications for use
The WEE-1200 Wireless Input Unit is intended to acquire, store, record, and transmit the cerebral and extracerebral activity for EEG and sleep studies. The device should be used together with Nihon Kohden specified electroencephalograph via wired or wireless communication to display EEG on the electroencephalograph screen. These data may be used by the clinician in sleep disorder, epilepsies and other related disorders as an aid in diagnosis. The WEE-1200 Wireless Input Unit is designed for use by qualified medical personnel in a medical facility such as a hospital or clinic on all patient populations including adult, neonate, infant, child and adolescent subgroups.

Source page: https://510kreport.com/device/K171124
Methodology: https://510kreport.com/methodology