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Empi

US

Last updated May 23, 2026

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US
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Catalogue (74)

Page 1 of 2
DeviceModel / ReferenceRegistriesClassStatus
Dupel Kit Iontophoresis Device 199518-001
FDA UDI
Class IIActive
Iontophoresis Dupel Blue Butterfly 2.0 mL 199334-001
FDA UDI
Class IIActive
Kit, Hybresis Controller 199587-001
FDA UDI
Class IIActive
Iontophoresis Electrode Large 4.0 mL 4"x4" Box of 12 198810-001
FDA UDI
Class IIActive
Iontophoresis Electrode Small 2.0 mL 3.75"x2.25" Box of 12 198808-001
FDA UDI
Class IIActive
Iontophoresis Electrode Medium Butterfly 2.0 mL Box of 12 199572-001
FDA UDI
Class IIActive
Iontophoresis Dupel Blue Medium - Standard 2.5 mL 199335-001
FDA UDI
Class IIActive
Iontophoresis Electrode Medium 2.0 mL 3"x3" Box of 12 198809-001
FDA UDI
Class IIActive
KIT, DUPEL II, w/SAFETY SOCKET 199437-001
FDA UDI
Class IIActive
Iontophoresis Dupel Blue Small 1.5mL 199332-001
FDA UDI
Class IIActive
Iontophoresis Dupel Blue Large 4.0 mL 199336-001
FDA UDI
Class IIActive
Kit Dupel II International complete w/safety socket 199438-001
FDA UDI
Class IIActive
Action Patch Electrode ~ box of 4 199488-001
FDA UDI
Class IIActive
Ass'y, Kit, Hybresis Charging Station 199586-001
FDA UDI
Class IIActive
Hybresis Iontophoresis Patch, Medium/Standard, Box of 6 199589-001
FDA UDI
Class IIActive
Focus Model 795 Unit K951951
FDA 510(k)
Class IIActive
Empi, Nms/Sue Cutaneous Electrode K854513
FDA 510(k)
Class IIActive
Small Vaginal/Rectal Electrode K983206
FDA 510(k)
Class IIActive
Tbd Tens Reusable Electrode K902195
FDA 510(k)
Class IIActive
Empi Model 984 Basix, Tens K841045
FDA 510(k)
Class IIActive
Empi Model 730 Nms K854775
FDA 510(k)
Class IIActive
Empi Logix Model 712 Nms, Tens K870168
FDA 510(k)
Class IIActive
Empi Model 720 Nms, Tens K861451
FDA 510(k)
Class IIActive
Dupel Ii Buffered Iontophoresis Electrodes K970491
FDA 510(k)
Class IIActive
Iontophoresis Device K903093
FDA 510(k)
Class IIActive
Model 980d Tens Neuropacer K792522
FDA 510(k)
Class IIActive
Select Tens, Model 4600s K061650
FDA 510(k)
Class IIActive
Empi, Model 489, Tens K890604
FDA 510(k)
Class IIActive
Empi Model 712, Logix, Nms K841382
FDA 510(k)
Class IIActive
Transcutaneous Elec. Nerve Stimulator K813501
FDA 510(k)
Class IIActive
Empi Model 710, Nms K811395
FDA 510(k)
Class IIActive
Hybresis Iontophoresis Drug Delivery System K072946
FDA 510(k)
Class IIActive
Innova Pelvic Floor Stimulation System K941911
FDA 510(k)
Class IIActive
Empi Active Transcutaneous Nerve Stimulator K090922
FDA 510(k)
Class IIActive
Empi, Model 1000 Hand Held Electrode K862231
FDA 510(k)
Class IIActive
Innova Rectal Reusable Electrode/Comfortpulse Regular Or Small Reusable Electrode K972054
FDA 510(k)
Class IIActive
Imported Pain Control Device K771885
FDA 510(k)
Class IIActive
Empi Model 712, Logix(tm), Nms K864010
FDA 510(k)
Class IIActive
Innosense Pelvic Floor Stimulation And Electromyography System K971527
FDA 510(k)
Class IIActive
Tbd Iontophoresis Electrode K896703
FDA 510(k)
Class IIActive
Innova Rectal Stimulaton Electrode K954272
FDA 510(k)
Class IIActive
Epix Xl Tens Unit K951903
FDA 510(k)
Class IIActive
Empi Tape Patches K941389
FDA 510(k)
Class IActive
Modified Island Tens Disp. Electrode For Snap Conn K896485
FDA 510(k)
Class IIActive
Innova Comfortpulse Vaginal Electrode (199204)/Innova Comfortpulse Small Vaginal Electrode(199205) K964577
FDA 510(k)
Class IIActive
Modified Island Snap Tens Disposable Electrode K901103
FDA 510(k)
Class IIActive
Empi Reuseable Pin-Style Tens Electrode K890747
FDA 510(k)
Class IIActive
Epix Vt K970203
FDA 510(k)
Class IIActive
Empi Model 727, Nms K882631
FDA 510(k)
Class IIActive
Innova Vaginal Emg Sensing Electrode K940091
FDA 510(k)
Class IIActive

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