FDA.reportPublic FDA data

Axon

Primary DI
09413000078510
Brand
Axon
Company
EXSURGO LIMITED
Model
Android
Catalog number
100321
Device description
Neurofeedback Software Application for Android
Published
2021-08-16
Public version status
New
Distribution status
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
09413000078510PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09413000078510094130000785109413000078510

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+6492183583info@exsurgo.com

Regulatory Flags#

DUNS number
594916540
Device count
1
Premarket exempt
true
Lot or batch
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
09413000078442AxonMedium1001602021-08-13
09413000078459AxonLarge1001612021-08-13
09413000095982Axon 21005001005002023-05-22

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