Axelgaard Mfg Co L T D

FDA Filings

This page includes the latest FDA filings for Axelgaard Mfg Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number2025066
FEI Number1000603528
NameAXELGAARD MFG. CO., LTD.
Owner & OperatorAXELGAARD MFG. CO., LTD.
Contact Address520 INDUSTRIAL WAY --
Fallbrook CA 92028 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address520 INDUSTRIAL WAY
FALLBROOK, CA 92028 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
AXELGAARD MFG. CO., LTD.
PALS Neurostimulation Electrodes2014-09-02
AXELGAARD MFG. CO., LTD.
PALS PLATINUM NEUROSTIMULATION ELECTRODES2014-02-13
AXELGAARD MFG. CO., LTD.
ValluTrode OTC Neurostimulation Electrodes2013-11-11
AXELGAARD MFG. CO., LTD.
VALUTRODE NEUROSTIMLATION ELECTRODES2013-07-17
AXELGAARD MFG. CO., LTD.
Comfort Iontophoresis Electrodes /2008-10-09
AXELGAARD MFG. CO., LTD.
Buffered Iontophoresis Electrodes2008-10-09
AXELGAARD MFG. CO., LTD.
COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D2008-06-18
AXELGAARD MFG. CO., LTD.
Everlast2008-01-16
AXELGAARD MFG. CO., LTD.
ValuTrode2008-01-16
AXELGAARD MFG. CO., LTD.
ValuTrode Lite2008-01-16
AXELGAARD MFG. CO., LTD.
PALS Flex2008-01-16
AXELGAARD MFG. CO., LTD.
PALS Platinum Electrodes2008-01-16
AXELGAARD MFG. CO., LTD.
PALS Platinum Blue2008-01-16
AXELGAARD MFG. CO., LTD.
UltraStim Kit2008-01-16
AXELGAARD MFG. CO., LTD.
UltraStim Kit2008-01-16
AXELGAARD MFG. CO., LTD.
UltraStim Kit2008-01-16
AXELGAARD MFG. CO., LTD.
UltraStim2008-01-16
AXELGAARD MFG. CO., LTD.
PALS NeoNatal2008-01-16
AXELGAARD MFG. CO., LTD.
Little PALS2008-01-16
AXELGAARD MFG. CO., LTD.
ULTRASTIM KIT2002-08-22
AXELGAARD MFG. CO., LTD.
ULTRASTIM ELECTRODE, MODEL US40402000-06-16
AXELGAARD MFG. CO., LTD.
PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN2002000-04-13
AXELGAARD MFG. CO., LTD.
EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL20201998-12-18
AXELGAARD MFG. CO., LTD.
VALUETRODE1997-05-09
AXELGAARD MFG. CO., LTD.
TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS)1988-01-28
AXELGAARD MFG. CO., LTD.
TENS PALS PLUS1987-09-22
AXELGAARD MFG. CO., LTD.
ELECTRICAL NERVE STIMULATION(TENS) ELECTRODES1985-06-18

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020091062353Pusan,South Korea -> Los Angeles, CaliforniaCABEL 8544.42-209088 PKG
2020082445973Pusan,South Korea -> Los Angeles, CaliforniaCABLE 8544.42-2090177 PKG
2020081865830Pusan,South Korea -> Los Angeles, CaliforniaCABLE 8544.42-2090177 PKG
2020080417606Pusan,South Korea -> Long Beach, CaliforniaCABLE 8544.42-2090143 PKG
2020072041064Pusan,South Korea -> Long Beach, CaliforniaCABLE 8544.42-2090143 PKG
2020070448232Pusan,South Korea -> Los Angeles, CaliforniaCABLE 8544.42-2090121 PKG
2020061956662Pusan,South Korea -> Los Angeles, CaliforniaCABLE 8544.42-209060 PKG
2020060947564Pusan,South Korea -> Los Angeles, CaliforniaCABLE 8544.42-2090136 PKG

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