CYMEDICA ORTHOPEDICS, INC.

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

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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) (9) Cyanomethemoglobin Reagent And Standard Solution (GJZ) (1)

Premarket Exempt

Yes No

Clear

e-vive NMES System with Post-Op Brace; Small/Medium, Left (2.0 Dock) - 00854691008353 Catalog Number : CY-1000-210

Device Description : e-vive NMES System with Post-Op Brace; Small/Medium, Left (2.0 Dock)

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 (2.0 Dock) - 00854691008360 Catalog Number : CY-1000-211

Device Description : e-vive NMES System with Post-Op Brace; Large/XL, Left (2.0 Dock)

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 (2.0 Dock) - 00854691008377 Catalog Number : CY-1000-212

Device Description : e-vive NMES System with Post-Op Brace; 2XL/3XL, Left (2.0 Dock)

Device Class : 1

Duns Number: 035596579

Premarket Exempt : No

Product Code : KQX, GZJ, IPF

Prescription Use : Yes

Device Count : 1

e-vive NMES System; Small/Medium, Right (2.0 Dock) - 00854691008384 Catalog Number : CY-1000-213

Device Description : e-vive NMES System; Small/Medium, Right (2.0 Dock)

Device Class : 1

Duns Number: 035596579

Premarket Exempt : No

Product Code : KQX, GZJ, IPF

Prescription Use : Yes

Device Count : 1

e-vive NMES System; Large/XL, Right (2.0 Dock) - 00854691008391 Catalog Number : CY-1000-214

Device Description : e-vive NMES System; Large/XL, Right (2.0 Dock)

Device Class : 1

Duns Number: 035596579

Premarket Exempt : No

Product Code : KQX, GZJ, IPF

Prescription Use : Yes

Device Count : 1

e-vive NMES System; 2XL/3XL, Right (2.0 Dock) - 00854691008407 Catalog Number : CY-1000-215

Device Description : e-vive NMES System; 2XL/3XL, Right (2.0 Dock)

Device Class : 1

Duns Number: 035596579

Premarket Exempt : No

Product Code : KQX, GZJ, IPF

Prescription Use : Yes

Device Count : 1

e-vive NMES System; Small/Medium, Left (2.0 Dock) - 00854691008414 Catalog Number : CY-1000-216

Device Description : e-vive NMES System; Small/Medium, Left (2.0 Dock)

Device Class : 1

Duns Number: 035596579

Premarket Exempt : No

Product Code : KQX, GJZ, IPF

Prescription Use : Yes

Device Count : 1

e-vive NMES System; Large/XL, Left (2.0 Dock) - 00854691008421 Catalog Number : CY-1000-217

Device Description : e-vive NMES System; Large/XL, Left (2.0 Dock)

Device Class : 1

Duns Number: 035596579

Premarket Exempt : No

Product Code : KQX, GZJ, IPF

Prescription Use : Yes

Device Count : 1

e-vive NMES System; 2XL/3XL, Left (2.0 Dock) - 00854691008438 Catalog Number : CY-1000-218

Device Description : e-vive NMES System; 2XL/3XL, Left (2.0 Dock)

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; Extra Small, Right (2.0 Dock) - 00854691008445 Catalog Number : CY-1000-219

Device Description : e-vive NMES System with Post-Op Brace; Extra Small, Right (2.0 Dock)

Device Class : 1

Duns Number: 035596579

Premarket Exempt : No

Product Code : KQX, GZJ, IPF

Prescription Use : Yes

Device Count : 1

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