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

Goniometer, Ac-Powered (KQX) (10) Stimulator, Muscle, Powered (IPF) (10) Stimulator, Nerve, Transcutaneous, For Pain Relief (GZJ) (10)

Premarket Exempt

Yes No

Clear

e-vive II NMES System; L/XL, Left (ITALIAN) - 00850022650109 Catalog Number : CY-1000-317I

Device Description : e-vive II NMES System; L/XL, Left (ITALIAN)

Device Class : 1

Duns Number: 035596579

Premarket Exempt : No

Product Code : IPF, GZJ, KQX

Prescription Use : Yes

Device Count : 1

e-vive II NMES System; 2XL/3XL, Left (ITALIAN) - 00850022650116 Catalog Number : CY-1000-318I

Device Description : e-vive II NMES System; 2XL/3XL, Left (ITALIAN)

Device Class : 1

Duns Number: 035596579

Premarket Exempt : No

Product Code : IPF, GZJ, KQX

Prescription Use : Yes

Device Count : 1

e-vive NMES System - 00854691008070 Catalog Number : CY-1000-046

Device Description : e-vive NMES System; Extra Small, Left, Bilateral Kit Label

Device Class : 1

Duns Number: 035596579

Premarket Exempt : No

Product Code : KQX, GZJ, IPF

Prescription Use : Yes

Device Count : 1

e-vive NMES System - 00854691008087 Catalog Number : CY-1000-051

Device Description : e-vive Bilateral NMES System; Small / Medium

Device Class : 1

Duns Number: 035596579

Premarket Exempt : No

Product Code : KQX, GZJ, IPF

Prescription Use : Yes

Device Count : 1

e-vive NMES System - 00854691008094 Catalog Number : CY-1000-052

Device Description : e-vive Bilateral NMES System; Large/XL

Device Class : 1

Duns Number: 035596579

Premarket Exempt : No

Product Code : KQX, GZJ, IPF

Prescription Use : Yes

Device Count : 1

e-vive NMES System - 00854691008100 Catalog Number : CY-1000-053

Device Description : e-vive Bilateral NMES System; 2X/3X

Device Class : 1

Duns Number: 035596579

Premarket Exempt : No

Product Code : KQX, GZJ, IPF

Prescription Use : Yes

Device Count : 1

e-vive NMES System - 00854691008117 Catalog Number : CY-1000-050

Device Description : e-vive Bilateral NMES System; Extra Small

Device Class : 1

Duns Number: 035596579

Premarket Exempt : No

Product Code : KQX, GZJ, IPF

Prescription Use : Yes

Device Count : 1

e-vive NMES System - 00854691008124 Catalog Number : CY-1000-121

Device Description : e-vive NMES System; Extra Small, 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 - 00854691008131 Catalog Number : CY-1000-122

Device Description : e-vive NMES System; Extra Small, 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 - 00854691008148 Catalog Number : CY-1000-119

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

Device Class : 1

Duns Number: 035596579

Premarket Exempt : No

Product Code : KQX, GZJ, IPF

Prescription Use : Yes

Device Count : 1

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