THERAGEN, LLC

THERAGEN, LLC

Address:25003 Pitkin Road Suite D800,Spring,TX,77386,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) (8) Electrode, Cutaneous (GXY) (2)

Premarket Exempt

No

Clear

Neurotech Kneehab - 00850372007004 Catalog Number :

Device Description : Neurotech Kneehab NMES+TENS Controller.

Device Class : 2

Duns Number: 080028759

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

Neurotech Aviva - 00850372007011 Catalog Number :

Device Description : AVIVASTIM XP 281 US RoHS

Device Class : 2

Duns Number: 080028759

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

Neurotech Kneehab - 00850372007028 Catalog Number :

Device Description : KNEEHAB PLUS GARMENT US RIGHT

Device Class : 2

Duns Number: 080028759

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

Neurotech Kneehab - 00850372007035 Catalog Number :

Device Description : KNEEHAB PLUS GARMENT US LEFT

Device Class : 2

Duns Number: 080028759

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

Neurotech Kneehab - 00850372007042 Catalog Number :

Device Description : KNEEHAB PLUS SMALL GARMENT US RIGHT

Device Class : 2

Duns Number: 080028759

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

Neurotech Kneehab - 00850372007059 Catalog Number :

Device Description : KNEEHAB PLUS SMALL GARMENT US LEFT

Device Class : 2

Duns Number: 080028759

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

Neurotech Kneehab - 00850372007066 Catalog Number : 0426-3302

Device Description : KNEEHAB+ TENS PROGRAMMED CABLE PACK

Device Class : 2

Duns Number: 080028759

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

Neurotech Recovery Back - 00850372007073 Catalog Number :

Device Description : RECOVERY BACK N AMERICA SMALL

Device Class : 2

Duns Number: 080028759

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Neurotech Recovery Back - 00850372007080 Catalog Number :

Device Description : RECOVERY BACK N AMERICA M/L

Device Class : 2

Duns Number: 080028759

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Neurotech Plus - 00850372007097 Catalog Number :

Device Description : NT+ NA CONTROLLER W/LEADWIRES + ELECTRODES

Device Class : 2

Duns Number: 080028759

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

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