AccessGUDID - DEVICE: Nexalin (B788KS02000)

GUDID

Device Identifier (DI) Information

Brand Name: Nexalin
Version or Model: KS02000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KS02000
Company Name: NEXALIN TECHNOLOGY

Primary DI Number: B788KS02000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 091477825 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
JXK	Stimulator, Cranial Electrotherapy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K024377	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 32ddd299-7f33-4985-be65-d9c643ce0906
Public Version Date: August 07, 2024
Public Version Number: 2
DI Record Publish Date: October 01, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

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

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

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

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES