AXELGAARD MANUFACTURING CO., LTD.

AXELGAARD MANUFACTURING CO., LTD.

Address:520 INDUSTRIAL WAY,FALLBROOK,CA,92028,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Electrode, Cutaneous (GXY) (6) Electrode, Electrocardiograph (DRX) (4)

Premarket Exempt

No

Clear

ValuTrode X Cloth - 00851913006005 Catalog Number :

Device Class : 2

Duns Number: 150959401

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

ValuTrode X Foam - 00851913006012 Catalog Number :

Device Class : 2

Duns Number: 150959401

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

ValuTrode X Tan Cloth - 00851913006029 Catalog Number :

Device Class : 2

Duns Number: 150959401

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

UltraStim X Blue - 00851913006036 Catalog Number :

Device Class : 2

Duns Number: 150959401

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

UltraStim X Blue - 00851913006043 Catalog Number :

Device Class : 2

Duns Number: 150959401

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

ValuTrode Cloth - 00851913006050 Catalog Number :

Device Class : 2

Duns Number: 150959401

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

Little PALS - 00851913006067 Catalog Number :

Device Class : 2

Duns Number: 150959401

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Little PALS - 00851913006074 Catalog Number :

Device Class : 2

Duns Number: 150959401

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Little PALS - 00851913006081 Catalog Number :

Device Class : 2

Duns Number: 150959401

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Little PALS - 00851913006098 Catalog Number :

Device Class : 2

Duns Number: 150959401

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

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