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) (10) Goniometer, Ac-Powered (KQX) (3) Stimulator, Nerve, Transcutaneous, For Pain Relief (GZJ) (3)

Premarket Exempt

No Yes

Clear

QB1 NMES System - 00854691008254 Catalog Number : QB-1000-216

Device Description : QB1 NMES System; S/M, Left

Device Class : 2

Duns Number: 035596579

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

QB1 NMES System - 00854691008261 Catalog Number : QB-1000-217

Device Description : QB1 NMES System; L/XL, Left

Device Class : 2

Duns Number: 035596579

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

QB1 NMES System - 00854691008278 Catalog Number : QB-1000-218

Device Description : QB1 NMES System; 2XL/3XL, Left

Device Class : 2

Duns Number: 035596579

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

QB1 NMES System - 00854691008285 Catalog Number : QB-1000-219

Device Description : QB1 NMES System with Post-Op Brace; XS, Right

Device Class : 2

Duns Number: 035596579

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

QB1 NMES System - 00854691008292 Catalog Number : QB-1000-220

Device Description : QB1 NMES System with Post-Op Brace; XS, Left

Device Class : 2

Duns Number: 035596579

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

QB1 NMES System - 00854691008308 Catalog Number : QB-1000-221

Device Description : QB1 NMES System; XS, Right

Device Class : 2

Duns Number: 035596579

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

QB1 NMES System - 00854691008315 Catalog Number : QB-1000-222

Device Description : QB1 NMES System; XS, Left

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 (2.0 Dock) - 00854691008322 Catalog Number : CY-1000-207

Device Description : e-vive NMES System with Post-Op Brace; 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 with Post-Op Brace; Large/XL, Right (2.0 Dock) - 00854691008339 Catalog Number : CY-1000-208

Device Description : e-vive NMES System with Post-Op Brace; 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 with Post-Op Brace; 2XL/3XL, Right (2.0 Dock) - 00854691008346 Catalog Number : CY-1000-209

Device Description : e-vive NMES System with Post-Op Brace; 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

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