# K051178: Mee-1000A Neuromaster

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden America, Inc.
- Decided: Aug 17, 2005 after 100 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- 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: 2 generations back to K950208 (1995). 2 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991899: Nihon Kohden Meb-2200A Neuropack Evoked Potential & Emg Measuring System with Accessories, Nihon Kohden America, Inc. (1999) Summary page 1.

## Most influential descendants
- K142624: Neuromaster G1 MEE200 (2015), 8 descendants of its own
- K162199: Cascade IOMAX Intraoperative Monitor (2017), 7 descendants of its own
- K212166: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (2022), 5 descendants of its own
- K233292: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (2023), 1 descendant of its own
- K221821: ATEC IOM Accessory Instruments (2022), 1 descendant of its own

## Recalls of this device
- Jan 19, 2012 · Class II · Z-0817-2016: The MEE-1000A Neuromaster had defective printed circuit boards (PCBs). Gas arrestors on these boards which were intended to provide protection from electrostatic discharge failed to prohibit unintenti

## Indications for use
Nihon Kohden's model number MEE-1000 is intended for medical purposes to measure, monitor, record and display the bioelectric signals produced by muscles (EMG), to stimulate peripheral nerves and to monitor, record and display the electrical activities produced by nerves to aid clinicians in the diagnosis and prognosis of neuromuscular disease. The device monitors electric/auditory/visual evoked potential, EEG and EMG. The device is also intended to measure and display nerve conduction time by applying a stimulus to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time. The device may use electrical stimulus, visual stimulus, or sound stimulus for use in evoked response measurements (EP). Continuous and/or periodic measurements of evoked potential activities are displayed and stored. The device applies an electrical stimulus to a patient thru commercially available skin electrodes for the purpose of measuring the evoked response. The photic stimulator is used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye and the auditory stimulator produces a sound stimulus for use in evoked response measurements or electroencephalogram activation. The device may be used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin. The device may also measure and record the electrical activities of the patient's brain obtained by placing two or more electrodes on the head (EEG). The acquired waveforms are displayed in cascaded format and measurement data may be displayed on the trendgraph with waveforms annotations (events). The acquired waveforms with the measurement data can be saved in a large capacity storage media. The device is intended for use by medical personnel within a hospital, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional. The device is available for use on any patient as determined by the medical professional including adults and children.

Source page: https://510kreport.com/device/K051178
Methodology: https://510kreport.com/methodology