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

No Yes

Clear

e-vive II NMES System with Post-Op Brace; S/M, Right (ITALIAN) - 00850022650000 Catalog Number : CY-1000-307I

Device Description : e-vive II NMES System with Post-Op Brace; S/M, Right (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 with Post-Op Brace; L/XL, Right (ITALIAN) - 00850022650017 Catalog Number : CY-1000-308I

Device Description : e-vive II NMES System with Post-Op Brace; L/XL, Right (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 with Post-Op Brace; 2XL/3XL, Right (ITALIAN) - 00850022650024 Catalog Number : CY-1000-309I

Device Description : e-vive II NMES System with Post-Op Brace; 2XL/3XL, Right (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 with Post-Op Brace; S/M, Left (ITALIAN) - 00850022650031 Catalog Number : CY-1000-310I

Device Description : e-vive II NMES System with Post-Op Brace; S/M, 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 with Post-Op Brace; L/XL, Left (ITALIAN) - 00850022650048 Catalog Number : CY-1000-311I

Device Description : e-vive II NMES System with Post-Op Brace; 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 with Post-Op Brace; 2XL/3XL, Left (ITALIAN) - 00850022650055 Catalog Number : CY-1000-312I

Device Description : e-vive II NMES System with Post-Op Brace; 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 II NMES System; S/M, Right (ITALIAN) - 00850022650062 Catalog Number : CY-1000-313I

Device Description : e-vive II NMES System; S/M, Right (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; L/XL, Right (ITALIAN) - 00850022650079 Catalog Number : CY-1000-314I

Device Description : e-vive II NMES System; L/XL, Right (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, Right (ITALIAN) - 00850022650086 Catalog Number : CY-1000-315I

Device Description : e-vive II NMES System; 2XL/3XL, Right (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; S/M, Left (ITALIAN) - 00850022650093 Catalog Number : CY-1000-316I

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

Device Class : 1

Duns Number: 035596579

Premarket Exempt : No

Product Code : IPF, GZJ, KQX

Prescription Use : Yes

Device Count : 1

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