ZYNEX MEDICAL, INC.

Address:9655 Maroon Circle,Englewood,CO,80112,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) (5) Stimulator, Muscle, Powered (IPF) (2) Stimulator, Nerve, Transcutaneous, For Pain Relief (GZJ) (2) Plethysmograph, Impedance (DSB) (1) Stimulator, Electrical, Non-Implantable, For Incontinence (KPI) (1) Device, Biofeedback (HCC) (1) Thermometer, Electronic, Clinical (FLL) (1) Interferential Current Therapy (LIH) (1) Oximeter (DQA) (1)

Premarket Exempt

Clear

NexWave - 00852670007007 Catalog Number :

Device Description : An electrotherapy device which offers the user a choice of three operational mod An electrotherapy device which offers the user a choice of three operational modes: IFC, TENS, and NMES.

Device Class : 2

Duns Number: 141582226

Premarket Exempt : No

Product Code : IPF, GZJ, LIH

Prescription Use : Yes

Device Count : 1

TruWave TENS - 00852670007021 Catalog Number :

Device Description : An electrotherapy device which provides symptomatic pain relief with Transcutane An electrotherapy device which provides symptomatic pain relief with Transcutaneous Electrical Nerve Stimulation

Device Class : 2

Duns Number: 141582226

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

NeuroMove - 00852670007038 Catalog Number :

Device Description : EMG-triggered NeuroMuscular stimulator to aid in stroke recovery

Device Class : 2

Duns Number: 141582226

Premarket Exempt : No

Product Code : IPF, HCC

Prescription Use : Yes

Device Count : 1

InWave - 00852670007052 Catalog Number :

Device Description : Electrotherapy device for treatment of urinary incontinence.

Device Class : 2

Duns Number: 141582226

Premarket Exempt : No

Product Code : KPI

Prescription Use : Yes

Device Count : 1

Zynex Medical Electrodes - 00852670007076 Catalog Number :

Device Description : Electrode 2” Round , 4 per Package

Device Class : 2

Duns Number: 141582226

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

Zynex Medical Electrodes - 00852670007083 Catalog Number :

Device Description : NM900, Electrodes, 2" Round, 1 set of 3 electrodes.

Device Class : 2

Duns Number: 141582226

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

Zynex Medical Electrodes - 00852670007090 Catalog Number :

Device Description : Electrodes, 2” Square for LBG, 4pk

Device Class : 2

Duns Number: 141582226

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Zynex Medical Electrodes - 00852670007106 Catalog Number :

Device Description : Belt-Electrode Garment, Large/Extra Large

Device Class : 2

Duns Number: 141582226

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Zynex Medical Electrodes - 00852670007113 Catalog Number :

Device Description : Belt-Electrode Garment, Small/Medium

Device Class : 2

Duns Number: 141582226

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

CM-1500 Wrist Cuff - 00852670007151 Catalog Number :

Device Description : Wrist Wearable for the use with the CM-1500 cardiac monitoring unit.

Device Class : 2

Duns Number: 141582226

Premarket Exempt : No

Product Code : DQA, FLL, DSB

Prescription Use : Yes

Device Count : 1

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