# K033475: Wireless Input Unit, Model Wee-1000A Series

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden America, Inc.
- Decided: Jan 7, 2004 after 65 days
- Product code: OLV (Standard Polysomnograph With 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: 1 generation back to K003175 (2000). 1 ancestor in all.
9 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003175: Compumedics Siesta System, Compumedics Limited (2000) Summary page 1.

## Most influential descendants
- K103140: Nicolet Wireless Eeg (2011), 7 descendants of its own
- K170441: ElectroTek (2017), 1 descendant of its own
- K162681: Enobio Wireless EEG (2017), 1 descendant of its own
- K151600: R-40 EEG  Amplifier (2015), 1 descendant of its own
- K261604: Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) (2026), 0 descendants of its own

## Indications for use
The device is intended to acquire, store, and transfer biophysical parameters to EEG machines for the purpose of assisting the diagnosis of neurological and slecp disorders, measurement and display of cerebral and extracerebral activity for EEG and Slesp Studies. These data, may be used by the clinician in Sleep Disorders, Epilepsics and other related disorders as a diagnostic tool, : The device is intended for use by medical personnel in any location within a medical facility, physician’s office, laboratory, clinic or nursing home or outside of a medical facility under supervision of a medical professional. The device will be available on all patient populations, including pediatrics.

Source page: https://510kreport.com/device/K033475
Methodology: https://510kreport.com/methodology