FDA.reportPublic FDA data

AXELGAARD MFG. CO., LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20250661000603528AXELGAARD MFG. CO., LTD.1N2026-01-01520 INDUSTRIAL WAY FALLBROOK CA US 92028

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
490271160606214K983741EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020GXY1998-12-18
490271910079301K970426VALUETRODEGXY1997-05-09
490272014412698K874469TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS)GXY1988-01-28
490271411298441K872976TENS PALS PLUSGXY1987-09-22
490271007561221K852267ELECTRICAL NERVE STIMULATION(TENS) ELECTRODESGXY1985-06-18
490271350747140K132422PALS PLATINUM NEUROSTIMULATION ELECTRODESGXY2014-02-13
490271601228342K130987VALUTRODE NEUROSTIMLATION ELECTRODESGXY2013-07-17
490271543924458K080580COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE DEGJ2008-06-18
490271527830983K013532ULTRASTIM KITGZJ2002-08-22
490271168133706K000947ULTRASTIM ELECTRODE, MODEL US4040GXY2000-06-16
490271321025532K000206PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200DRX2000-04-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GXY92014-02-13
DRX22000-04-13
EGJ12008-06-18
GZJ12002-08-22

PMN#