DEVICE: Feedback Box (00817020020426)
Device Identifier (DI) Information
Feedback Box
M025500D
In Commercial Distribution
INTELLIGENT HEARING SYSTEMS CORP.
M025500D
In Commercial Distribution
INTELLIGENT HEARING SYSTEMS CORP.
Feedback Box for use with USB Jr Duet
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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10396 | Biofeedback system |
An assembly of devices intended to provide visual and/or auditory signals corresponding to the status of one or more of a patient's physiological functions, e.g., brain wave activity, muscle activity, blood pressure, skin temperature, balance, so that the patient can develop some degree of conscious control over a usually involuntarily function. This system will detect changes in the physiological functions that are outside of the normal awareness, amplify these signals, and provide this as feedback to the patient. It is used in, e.g., tension headache control, muscle relaxation, rehabilitation/training, behavioural research.
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Obsolete | false |
11614 | Evoked-potential graphic recording system |
An assembly of devices designed for recording a localized electrical potential from the brain or spinal cord in response to stimulation (i.e., visual, auditory, and/or somatosensory) of the sensory organs, or of some point along the ascending pathway from the sensory organs, or within the central nervous system. It typically includes a sensory stimulator/stimulation system and a graphic recorder. The characteristics of the recorded potential vary with recording location, stimulus modality and level, and level of consciousness or anaesthesia. The resultant waveform may be used to assess the function and integrity of the brain and its sensory pathways.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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GWJ | Stimulator, Auditory, Evoked Response |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K163326 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
8ae5732b-2dbb-4898-b1e7-f63ee77c9bb4
July 06, 2018
3
November 10, 2017
July 06, 2018
3
November 10, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined