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Nexalin KS02001

by Nexalin Technology, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB788KS02001 UDI-DI Date7 Oct 2019ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Nexalin
Generic Name
Transcranial electrical stimulation system, continuous-current, professional
Model / Ref / Catalog
KS02001
Primary DI / UDI-DI
B788KS02001
510(k) Number
FDA Product Code
JXK
GMDN Term
Transcranial electrical stimulation system, continuous-current, professional
Device Class
Class III
Regulation Number
882.5800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Transcranial electrical stimulation system, continuous-current, professional

Cleared under the same submission (K024377)

Other devices from Nexalin Technology, Inc.

Properties

  • Prescription Use

Other properties (13)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No