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Flow Neuroscience FL-PADS-48

by Flow Neuroscience AB GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number17314585010010 UDI-DIDate24 Jul 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Flow Neuroscience
Generic Name
Transcranial electrical stimulation system, continuous-current, home-use
Model / Ref / Catalog
FL-PADS-48
Description
Kit for US market comprises of: 1x 17314585010003 (one box of 24 PADS)
Primary DI / UDI-DI
17314585010010
PMA Number
FDA Product Code
JXK
GMDN Term
Transcranial electrical stimulation system, continuous-current, home-use
Device Class
Class III
Regulation Number
882.5800
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (P230024)

Other devices from Flow Neuroscience AB

Properties

  • Single Use
  • Prescription Use

Other properties (12)

  • Sterile: 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