Exel International Medical Products,
Medtronic, Inc.,
MYCO Medical,
more...
Medtronic, Inc.,
CareTrax Neuro Inc.
Medtronic, Inc.
Medtronic, Inc.
Medtronic, Inc.
Medtronic, Inc.
Medtronic, Inc.
Medtronic, Inc.
Medtronic, Inc.
Medtronic, Inc.
Nihon Kohden America, Inc.,
Cadwell Laboratories, Inc.,
Embla,
more...
Nihon Kohden America, Inc.,
WR Medical Electronics Co.,
Cadwell Laboratories, Inc.,
more...
(FDA Code:
GWS /
882.142)
Identification. An electroencephalogram (EEG) signal spectrum analyzer is a device used to display the frequency content or power spectral density of the electroencephalogram (EEG) signal.
Classification. Class I (general controls).
Nihon Kohden America, Inc.,
Bio-Logic Systems Corp.,
Draeger Medical, Inc.,
more...
Nihon Kohden America, Inc.,
Bio-Logic Systems Corp.,
Aspect Medical Systems, Inc.,
more...
(FDA Code:
GYA /
882.141)
Identification. An electroencephalograph electrode/lead tester is a device used for testing the impedance (resistance to alternating current) of the electrode and lead system of an electroencephalograph to assure that an adequate contact is made between the electrode and the skin.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 882.9.
Nihon Kohden America, Inc.,
Cadwell Laboratories, Inc.,
Rochester Electro-Medical, Inc.,
more...
(FDA Code:
GWR /
882.143)
Identification. An electroencephalograph test signal generator is a device used to test or calibrate an electroencephalograph.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 882.9.
Netech Corp.,
Neurotronics,
Invivo
PMT Corporation,
Electro-Cap International, Inc.,
Micron Products, Inc.,
more...
(FDA Code:
GWQ /
882.14)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.
Classification. Class II (performance standards).
Nihon Kohden America, Inc.,
Futuremed America. Inc.,
4-D Neuroimaging,
more...
Ambulatory EEG system includes a self-powered recording instrument adapted to be worn by a patient. The recording apparatus includes an A/D converter and a digital memory capable of storing digital data representing analog waveform signals derived from a large number of electrodes secured to the patient. Recording of digital waveform data is governed by a controller, which upon the occurrence of a neurologically significant event causes the storage of waveform data over an interval immediately preceding the event and immediately following the event.
Cadwell Laboratories, Inc.,
Graphic Controls LLC,
Lifelines Ltd.,
more...
Cadwell Laboratories, Inc.
Cortical stimulator is a medical device, which is used to revive neural activity in the nervous system of critical patients by delivering an electrical shock to induce brain activity. It is almost always attached to the temples or foreheads of humanoids. It is an electronic instrument used in nerve and mental therapy to deliver an electric shock of prescribed strength by means of a pulsating current.
Universal Medical Systems, Inc
Integra LifeSciences Corporation,
Grass Technologies,
Universal Medical Systems, Inc,
more...
Neuromuscular stimulators are designed to electronically stimulate muscles for people managing chronic or acute pain. It has dual channels and a pulse frequency. This stimulator also includes an adjustable contraction and relaxtion variable control of 1-10 seconds.
Grass Technologies,
Neural Signals,Inc.,
Universal Medical Systems, Inc,
more...
Nihon Kohden America, Inc.,
Bio-Logic Systems Corp.,
Electrical Geodesics, Inc.,
more...
Integrated Surgical Systems,
MPE, Inc.,
Ant B.V.,
more...
Neurodyne Medical Corp.,
Biomedical Instruments, Inc.,
Laborie Medical Technologies,
more...
Electromyography (EMG) is used to diagnose nerve and muscle diseases. It is a technique for evaluating and recording physiologic properties of muscles at rest and while contracting. EMG is performed using an instrument called an electromyograph. It detects the electrical potential generated by muscle cells when these cells contract, and also when the cells are at rest.
RedTech, Inc.,
Nihon Kohden America, Inc.,
Vyaire Medical, Inc.,
more...
Electromyography machine is an electrical recording machine of muscle activity that aids in the diagnosis of neuromuscular disease. It is used to measure nerve transmission and activity characteristics. Measurements can be the result of an applied stimulus or free-running measurement of nerve activity. It can help diagnose many muscle and nerve disorders, including muscular dystrophy, congenital myopathies, mitochondrial myopathies, metabolic myopathies, and myotonias.
Nihon Kohden America, Inc.,
A4 Health Systems,
Cadwell Laboratories, Inc.,
more...
A4 Health Systems,
Barrett Engineering
1st Providers Choice,
CureMD,
MedPACS Display, Inc.
Electronystagmography is a study used to clinically evaluate patients with dizziness, vertigo, or balance dysfunction. It provides exact measurements of eye movements rather than the objective observation of standard caloric stimulation. It can record behind closed eyelids or with the head in a variety of positions. It is used to determine whether a balance or nerve disorder is the cause of dizziness or vertigo.
Baxter International Inc,
GN Otometrics A/S
Electronystagmography (ENG) systems are used to evaluate people with vertigo and certain other disorders that affect hearing and vision. Electrodes are placed at locations above and below the eye to record electrical activity. By measuring the changes in the electrical field within the eye, ENG can detect nystagmus in response to various stimuli. If nystagmus does not occur upon stimulation, a problem may exist within the ear, nerves that supply the ear, or certain parts of the brain.
Baxter International Inc,
GN Otometrics A/S
(FDA Code:
HAM /
878.44)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.
Classification. Class II.
Medtronic Xomed Surgical Products, Inc,
Bovie Medical Corporation,
Kirwan Surgical Products,
more...
Cardima, Inc.,
Nuvasive Inc.,
Bard Electrophysiology,
more...
Better Life Devices Corp.,
Medical Electronics Inc,
Tensnet,
more...
Minnesota Wire & Cable Co.,
Evergreen Sales & Marketing, Inc.,
The Electrode Store
EMG cables are used for monitoring EMG while immersed in water.
Medtronic, Inc.
Nihon Kohden America, Inc.,
T-DOC Company, LLC,
Medtronic, Inc.,
more...
RedTech, Inc.,
Nihon Kohden America, Inc.,
Biomedical Instruments, Inc.,
more...
Nihon Kohden America, Inc.,
Vyaire Medical, Inc.,
Cadwell Laboratories, Inc.,
more...
(FDA Code:
GYE /
882.1855)
Identification. An electroencephalogram (EEG) telemetry system consists of transmitters, receivers, and other components used for remotely monitoring or measuring EEG signals by means of radio or telephone transmission systems.
Classification. Class II (performance standards).
Vyaire Medical, Inc.,
IDX Systems Corporation,
Criticare Systems, Inc.,
more...
Jedmed Instrument Company,
Integra LifeSciences Corporation,
Kronner Medical Manufacturing,
more...
Sonoma Health Products, Inc.,
Olympus America, Inc.,
Dp Medical Systems Ltd.,
more...
Gereonics, Inc.,
Mvap Medical Supplies, Inc.,
Embla,
more...
Adinstruments, Inc
Vyaire Medical, Inc.,
Gereonics, Inc.,
Embla,
more...
Vitae Core,
Alsius Corporation,
Bentec Medical,Inc.,
more...
Mvap Medical Supplies, Inc.,
Embla,
S.l.p. Inc.,
more...
(FDA Code:
GXB /
882.15)
Identification. An esthesiometer is a mechanical device which usually consists of a single rod or fiber which is held in the fingers of the physician or other examiner and which is used to determine whether a patient has tactile sensitivity.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180 of this chapter, with respect to general requirements concerning records, and 820.198 of this chapter, with respect to complaint files.
WR Medical Electronics Co.,
Cadwell Laboratories, Inc.,
Northcoast Medical, Inc.,
more...
Nihon Kohden America, Inc.,
Embla,
Nonin Medical, Inc.,
more...