DEVICE: Nexalin (B788KS02001)

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Device Record History
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Device Identifier (DI) Information
Nexalin
KS02001
In Commercial Distribution
KS02001
NEXALIN TECHNOLOGY
B788KS02001
HIBCC

1
091477825 *Terms of Use
Patient cable for transcranial electrical stimulation (TES)
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Device Characteristics
Labeling does not contain MRI Safety Information
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Yes
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GMDN

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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?
62056 Transcranial electrical stimulation system, continuous-current, professional
A noninvasive assembly of electrically-powered devices designed to apply weak continuous (not pulsed) electrical current (typically up to 2 mA) across the skin to a patient's brain as a therapy for one or more psychiatric/neurological indications such as depression, neuropathic pain, speech rehabilitation, motor skills recovery after stroke, and auditory hallucinations in schizophrenia. It is intended to be used within a healthcare facility for one or more therapy types [e.g., transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS)]. It includes a current generator, cables, scalp electrodes, and may include additional accessories.
Active false
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FDA Product Code

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Product Code Product Code Name
JXK Stimulator, Cranial Electrotherapy
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K024377 000
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
db10f4da-bd45-4caa-b678-961779a28a18
August 07, 2024
2
October 07, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
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Customer Contact

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No Customer Contact currently defined
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