Roscoe Medical

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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, Nerve, Transcutaneous, For Pain Relief (GZJ) (5) Cable, Electrode (IKD) (3) Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (IMG) (2)

Premarket Exempt

No Yes

Clear

N/A - 00092237616444 Catalog Number :

Device Description : 5cm Sound Head - 2nd Gen

Device Class : 2

Duns Number: 022542271

Premarket Exempt : No

Product Code : IMG

Prescription Use : Yes

Device Count : 1

N/A - 00092237616659 Catalog Number :

Device Description : EMS 7500 2nd Gen - Digital EMS

Device Class : 2

Duns Number: 022542271

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

N/A - 00092237616680 Catalog Number :

Device Description : InTENSity IF Combo (TENS/IF)

Device Class : 2

Duns Number: 022542271

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

N/A - 00092237616703 Catalog Number :

Device Description : InTENSity Select Combo -

Device Class : 2

Duns Number: 022542271

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

N/A - 00092237616741 Catalog Number :

Device Description : SoundCare Plus - Professional

Device Class : 2

Duns Number: 022542271

Premarket Exempt : No

Product Code : IMG

Prescription Use : Yes

Device Count : 1

N/A - 00092237616758 Catalog Number :

Device Description : Twin Stim 2nd - TENS/EMS

Device Class : 2

Duns Number: 022542271

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

N/A - 00092237616765 Catalog Number :

Device Description : TwinStim Plus 2nd Edition

Device Class : 2

Duns Number: 022542271

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

N/A - 00092237617342 Catalog Number :

Device Description : Lead Wires for Quattro 2/2.5 &

Device Class :

Duns Number: 022542271

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 2

N/A - 00092237617366 Catalog Number :

Device Description : 78 Clinical Lead Wires

Device Class :

Duns Number: 022542271

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 2

N/A - 00092237617373 Catalog Number :

Device Description : 78 Single (Combination) Lead

Device Class : 2

Duns Number: 022542271

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 1

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