# K073557: Eeg Neuroamp, Model CS10137

- Pathway: 510(k) (Traditional)
- Applicant: Corscience GmbH & Co. KG
- Decided: Feb 28, 2008 after 71 days
- Product code: HCC (Device, Biofeedback)
- Device class: 2
- Regulation: 21 CFR 882.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K920038 (1995). 5 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903497: Flexcomp DSP & Procomp, Thought Technology, Ltd. (1991) Summary page 2.
- K990538: Brainmaster 2E Module and Software Biofeedback Device, Brainmaster (1999) Summary page 2.

## Most influential descendants
- K122879: EEGER4 Model 4.3 (2013), 1 descendant of its own
- K222101: Prism (2023), 0 descendants of its own
- K193159: NeuroAmp II, NeuroAmp II.5s (2020), 0 descendants of its own

## Recalls of this device
- Nov 15, 2012 · Class II · Z-0526-2013: EEG Info, Inc. is recalling the EEG Neuroamp device because they have identified a potential risk associated with the mislabeling of certain devices.

## Indications for use
The EEG NeuroAmp is intended for biofeedback and relaxation purposes. To perform its intended function it must be used in combination with a computer and appropriate software. For purposes of this training task, information for feedback maybe derived from one or two channels of EEG and from as many as three channels of pripheral physiology measures such as are conventionally used in biofeedback The EEG NeuroAmp is intended to be used in the office by trained professionals who can ensure sound handling practices. The EEG NeuroAmp is not intended for diagnostic purposes. "Federal law restricts this device to sale by or on the order of a physician or any other practitioner licensed by the law of the State in which he practices to use or order the use of the device."

Source page: https://510kreport.com/device/K073557
Methodology: https://510kreport.com/methodology