Lifelines iEEG Portable Laptop System Wireless
The Lifelines iEEG Portable Laptop System Wireless acquires, displays, stores and analyzes EEG and other physiological signals. Its amplifier communicates wirelessly with the computer, and…
The Lifelines iEEG Portable Laptop System Wireless acquires, displays, stores and analyzes EEG and other physiological signals. Its amplifier communicates wirelessly with the computer, and the system can acquire digital video synchronized with the EEG.
Review tools include re-montaging, band pass filtering, FFT analysis and artifact removal. Quantitative EEG plots display power spectrum information to support examination of the recorded signals. The system combines acquisition and review software with an EEG amplifier and computer.
Use Settings
The system is intended for qualified medical practitioners trained in electroencephalography, in hospitals, clinics and patient homes. It supports all age groups and requires professional interpretation of the information; it does not provide a diagnostic conclusion.
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Kvikna Medical ehf, IS |
|---|---|
| FDA product code | OLT |
| Device type | Non-Normalizing Quantitative Electroencephalograph Software |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K143487 |
| Record published | 2016-08-18 |
| Record revised | 2022-11-28 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2018-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KHW1030 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Non-Normalizing Quantitative Electroencephalograph Software | Nihon Kohden America, Inc. | 28 |
| Non-Normalizing Quantitative Electroencephalograph Software | Nihon Kohden Corp. | 18 |
| Neurofax | Nihon Kohden America, Inc. | 14 |
| Stratus EEG | Kvikna Medical ehf | 4 |
| Nihon Kohden, EEG-1200A Series Neurofax | Nihon Kohden Corp. | 4 |
| Component Neuromonitoring System | Moberg Research, Inc. | 3 |
| Easy III | Cadwell Industries, Inc. | 3 |
| GCX | Nihon Kohden America, Inc. | 3 |
| Neurofax | Nihon Kohden Corp. | 2 |
| Non-Normalizing Quantitative Electroencephalograph Software | GE Healthcare Finland OY | 2 |
| E-Eegx | GE Healthcare Finland OY | 1 |
| Lifelines iEEG Portable Yoga Tablet No Video | Kvikna Medical ehf | 1 |
Showing 12 of 38. All products under Non-Normalizing Quantitative Electroencephalograph Software
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K143487 | 2015-08-21 |
| K123665 | 2013-03-25 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.