FDA UDI
In Commercial Distribution
🇺🇸 United States
Nexalin
DI: B788KS02000
·
Model: KS02000
·
NEXALIN TECHNOLOGY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Nexalin
- Primary DI
- B788KS02000
- Version / Model
- KS02000
- Catalog Number
- KS02000
- Company Name
- NEXALIN TECHNOLOGY
- Labeler DUNS
- 091477825
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-01
- Public Version
- 1
- Public Version Date
- 2019-10-09
- Public Version Status
- New
- Public Device Record Key
- 32ddd299-7f33-4985-be65-d9c643ce0906
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JXK | Stimulator, Cranial Electrotherapy | Neurology | 882.5800 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62056 | Transcranial electrical stimulation system, continuous-current | A noninvasive assembly of mains electricity (AC-powered) devices, which may include a rechargeable battery, designed to apply weak continuous (not pulsed) electrical current (typically up to 2 mA) across the skin to a patients 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 may be intended 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B788KS02000 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K024377 | 000 |