EMPI, INC.

EMPI, INC.

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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

Device, Iontophoresis, Other Uses (EGJ) (10)

Premarket Exempt

No Yes

Clear

Trans QE Medium 2.5-3.0 cc electrode, Box of 12 - 00888912024075 Catalog Number :

Device Class : 2

Duns Number: 039375910

Premarket Exempt : No

Product Code : EGJ

Prescription Use : Yes

Device Count : 1

Iogel Small 1.5 cc electrode, Box of 12 - 00888912024082 Catalog Number :

Device Class : 2

Duns Number: 039375910

Premarket Exempt : No

Product Code : EGJ

Prescription Use : Yes

Device Count : 1

Kit, Hybresis Controller - 00888912151252 Catalog Number :

Device Class : 2

Duns Number: 039375910

Premarket Exempt : No

Product Code : EGJ

Prescription Use : Yes

Device Count : 1

Hybresis Iontophoresis Patch, Medium/Standard, Box of 6 - 00888912151269 Catalog Number :

Device Class : 2

Duns Number: 039375910

Premarket Exempt : No

Product Code : EGJ

Prescription Use : Yes

Device Count : 1

Ass'y, Kit, Hybresis Charging Station - 00888912151276 Catalog Number :

Device Class : 2

Duns Number: 039375910

Premarket Exempt : Yes

Product Code : EGJ

Prescription Use : No

Device Count : 1

Action Patch Electrode ~ box of 4 - 00888912151283 Catalog Number :

Device Class : 2

Duns Number: 039375910

Premarket Exempt : No

Product Code : EGJ

Prescription Use : Yes

Device Count : 1

Iontophoresis Electrode Small 2.0 mL 3.75"x2.25" Box of 12 - 00888912151290 Catalog Number :

Device Class : 2

Duns Number: 039375910

Premarket Exempt : No

Product Code : EGJ

Prescription Use : Yes

Device Count : 1

Iontophoresis Electrode Medium 2.0 mL 3"x3" Box of 12 - 00888912151306 Catalog Number :

Device Class : 2

Duns Number: 039375910

Premarket Exempt : No

Product Code : EGJ

Prescription Use : Yes

Device Count : 1

Iontophoresis Electrode Large 4.0 mL 4"x4" Box of 12 - 00888912151313 Catalog Number :

Device Class : 2

Duns Number: 039375910

Premarket Exempt : No

Product Code : EGJ

Prescription Use : Yes

Device Count : 1

Iontophoresis Electrode Medium Butterfly 2.0 mL Box of 12 - 00888912151320 Catalog Number :

Device Class : 2

Duns Number: 039375910

Premarket Exempt : No

Product Code : EGJ

Prescription Use : Yes

Device Count : 1

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