Emsi

Address:3504 CRAGMONT DR., STE. 100,TAMPA,FL,33619,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

Interferential Current Therapy (LIH) (5) Stimulator, Nerve, Transcutaneous, For Pain Relief (GZJ) (5) Electrode, Cutaneous (GXY) (3) Stimulator, Muscle, Powered (IPF) (2)

Premarket Exempt

Clear

Flex-TENS - 00858688006001 Catalog Number :

Device Class : 2

Duns Number: 932471881

Premarket Exempt : No

Product Code : LIH, GZJ

Prescription Use : Yes

Device Count : 1

Flex-IT - 00858688006018 Catalog Number :

Device Description : FLEI0001

Device Class : 2

Duns Number: 932471881

Premarket Exempt : No

Product Code : LIH

Prescription Use : Yes

Device Count : 1

Flex-MT Plus - 00858688006025 Catalog Number :

Device Class : 2

Duns Number: 932471881

Premarket Exempt : No

Product Code : GZJ, IPF

Prescription Use : Yes

Device Count : 1

IF-5000 - 00858688006032 Catalog Number :

Device Class : 2

Duns Number: 932471881

Premarket Exempt : No

Product Code : LIH

Prescription Use : No

Device Count : 1

Flex Gar Sleeve - 00858688006049 Catalog Number :

Device Class : 2

Duns Number: 932471881

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

EMSI 40 x 40 Electrode - 00858688006056 Catalog Number :

Device Class : 2

Duns Number: 932471881

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

EMSI 45 x 45 Electrical Stimulation Electrode - 00858688006063 Catalog Number :

Device Class : 2

Duns Number: 932471881

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

Flex-IT Retail - 00858688006070 Catalog Number :

Device Description : device + electrodes

Device Class : 2

Duns Number: 932471881

Premarket Exempt : No

Product Code : GZJ, LIH

Prescription Use : Yes

Device Count : 1

Flex-TENS Retail - 00858688006087 Catalog Number :

Device Description : (device + electrodes)

Device Class : 2

Duns Number: 932471881

Premarket Exempt : No

Product Code : GZJ, LIH

Prescription Use : Yes

Device Count : 1

Flex-MT Plus Retail - 00858688006094 Catalog Number :

Device Description : device + electrodes

Device Class : 2

Duns Number: 932471881

Premarket Exempt : No

Product Code : IPF, GZJ

Prescription Use : Yes

Device Count : 1

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