CYMEDICA ORTHOPEDICS, INC.

Address:2120 East 6th Street,Tempe,AZ,85281,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

Stimulator, Muscle, Powered (IPF) (8) Goniometer, Ac-Powered (KQX) (7) Stimulator, Nerve, Transcutaneous, For Pain Relief (GZJ) (7) Electrode, Cutaneous (GXY) (2)

Premarket Exempt

No Yes

Clear

CyMedica e-vive™ NMES Electrode Set without Backings - 00854816006752 Catalog Number : CY-1000-020

Device Description : CyMedica e-vive™ NMES Electrode Set without Backings

Device Class : 2

Duns Number: 035596579

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

CyMedica e-vive TENS Electrode Set - 00854816006769 Catalog Number : CY-1000-021

Device Description : CyMedica e-vive TENS Electrode Set

Device Class : 2

Duns Number: 035596579

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

e-vive Electrode Covers - 00854816006790 Catalog Number : CY-1000-034

Device Description : e-vive Electrode Covers

Device Class : 1

Duns Number: 035596579

Premarket Exempt : No

Product Code : KQX, GZJ, IPF

Prescription Use : Yes

Device Count : 1

QB1 Garment Strap Extender Kit - 00854816006806 Catalog Number : QB-1000-176

Device Description : QB1 Garment Strap Extender Kit

Device Class : 2

Duns Number: 035596579

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

e-vive NMES System with Post-Op Brace; Small/Medium, Right - 00854816006813 Catalog Number : CY-1000-107

Device Description : e-vive NMES System with Post-Op Brace; Small/Medium, Right

Device Class : 1

Duns Number: 035596579

Premarket Exempt : No

Product Code : KQX, GZJ, IPF

Prescription Use : Yes

Device Count : 1

e-vive NMES System with Post-Op Brace; Large/XL, Right - 00854816006820 Catalog Number : CY-1000-108

Device Description : e-vive NMES System with Post-Op Brace; Large/XL, Right

Device Class : 1

Duns Number: 035596579

Premarket Exempt : No

Product Code : KQX, GZJ, IPF

Prescription Use : Yes

Device Count : 1

e-vive NMES System with Post-Op Brace; 2XL/3XL, Right - 00854816006837 Catalog Number : CY-1000-109

Device Description : e-vive NMES System with Post-Op Brace; 2XL/3XL, Right

Device Class : 1

Duns Number: 035596579

Premarket Exempt : No

Product Code : KQX, GZJ, IPF

Prescription Use : Yes

Device Count : 1

e-vive NMES System with Post-Op Brace; Small/Medium, Left - 00854816006844 Catalog Number : CY-1000-110

Device Description : e-vive NMES System with Post-Op Brace; Small/Medium, Left

Device Class : 1

Duns Number: 035596579

Premarket Exempt : No

Product Code : KQX, GZJ, IPF

Prescription Use : Yes

Device Count : 1

e-vive NMES System with Post-Op Brace; Large/XL, Left - 00854816006851 Catalog Number : CY-1000-111

Device Description : e-vive NMES System with Post-Op Brace; Large/XL, Left

Device Class : 1

Duns Number: 035596579

Premarket Exempt : No

Product Code : KQX, GZJ, IPF

Prescription Use : Yes

Device Count : 1

e-vive NMES System with Post-Op Brace; 2XL/3XL, Left - 00854816006868 Catalog Number : CY-1000-112

Device Description : e-vive NMES System with Post-Op Brace; 2XL/3XL, Left

Device Class : 1

Duns Number: 035596579

Premarket Exempt : No

Product Code : KQX, GZJ, IPF

Prescription Use : Yes

Device Count : 1

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