FDA.reportPublic FDA data

Axon

Primary DI
09413000078442
Brand
Axon
Company
EXSURGO LIMITED
Model
Medium
Catalog number
100160
Device description
Neurofeedback Kit - Mediumincludes Axon EEG headset - Medium, Tablet with Axon Neurofeedback Software Application
Published
2021-08-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCCDevice, Biofeedback

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09413000078442PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09413000078442094130000784429413000078442

GMDN Terms#

Term, Definition table
TermDefinition
Psychophysiological biofeedback systemA computerized device assembly designed for analysis and real-time feedback (biofeedback) of a variety of physiological parameters [e.g., heart rate, respiration, skin conductance, skin temperature, range of motion, force output, electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG) data] to assist a patient in developing a degree of conscious control over typically involuntary functions, usually for relaxation training and muscle re-education. It includes multiple pieces of patient monitoring hardware (e.g., electrodes, sensors), computer interface devices, and dedicated software; it is intended to be used with an off-the-shelf computer.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius55 Degrees Celsius
Storage Environment Temperature32 Degrees Fahrenheit131 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+642183583info@exsurgo.com

Regulatory Flags#

DUNS number
594916540
Device count
1
Premarket exempt
true
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09413000107500AxoniOS1003182025-01-15
09413000077094AxonMedium1001422021-08-13
09413000078411AxonSmall1001412021-08-13
09413000078428AxonLarge1001432021-08-13
09413000078435AxonSmall1001402021-08-13
09413000078459AxonLarge1001612021-08-13
09413000095982Axon 21005001005002023-05-22
09413000078510AxonAndroid1003212021-08-16

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Primary DI, Brand, Company table
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04560340091794Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091800Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
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04560340091824Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
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