BIO PROTECH USA, INC.

Address:13620 Benson Ave,Chino,CA,91710,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

Electrode, Electrocardiograph (DRX) (5) Stimulator, Muscle, Powered (IPF) (2) Stimulator, Nerve, Transcutaneous, For Pain Relief (GZJ) (2) Interferential Current Therapy (LIH) (1)

Premarket Exempt

No Yes

Clear

Bio Protech - 00817120020005 Catalog Number :

Device Description : MaxTens 1k - Analog Tens Unit

Device Class : 2

Duns Number: 789127011

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020036 Catalog Number :

Device Description : MaxTens 2k - Digital Tens Unit

Device Class :

Duns Number: 789127011

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020043 Catalog Number :

Device Description : MaxIF 1k Unit- Interferential Analog Unit

Device Class : 2

Duns Number: 789127011

Premarket Exempt : No

Product Code : LIH

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020074 Catalog Number :

Device Description : MaxEMS 1k - Analog EMS Unit

Device Class : 2

Duns Number: 789127011

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020081 Catalog Number :

Device Description : MaxEMS 2k - Digital EMS Unit

Device Class : 2

Duns Number: 789127011

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020098 Catalog Number :

Device Description : T715-50: TElectrodes, PE Foam, 55mm Round, General, Stress, & Holter, 50/ per po T715-50: TElectrodes, PE Foam, 55mm Round, General, Stress, & Holter, 50/ per pouch, 20 pouch/box, 1,000/pcs per master case

Device Class : 2

Duns Number: 789127011

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020104 Catalog Number :

Device Description : T716-3: TElectrode, 43mm x 45mm Oval, PE Foam, General, Stress & Holter, 3/pc pe T716-3: TElectrode, 43mm x 45mm Oval, PE Foam, General, Stress & Holter, 3/pc per pouch, 20 pouches/box, 10/box/per case, 600 pcs Master Case

Device Class :

Duns Number: 789127011

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020111 Catalog Number :

Device Description : T716-30: TElectrodes, 43mm x 45mm Oval, PE Foam, General, Stress & Holter, 30pc/ T716-30: TElectrodes, 43mm x 45mm Oval, PE Foam, General, Stress & Holter, 30pc/pouch, 20pouch/box, 600 pcs/per master case

Device Class :

Duns Number: 789127011

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020128 Catalog Number :

Device Description : T716-5: TElectrode, 43mm x 45mm Oval, PE Foam, General, Stress & Holter, 5 pc/po T716-5: TElectrode, 43mm x 45mm Oval, PE Foam, General, Stress & Holter, 5 pc/pouch, 20 pouches/box, 10 boxes/ case, 1,000 pcs per master case

Device Class :

Duns Number: 789127011

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020135 Catalog Number :

Device Description : T716-50: TElectrode, 43mm x 45mm Oval, PE Foam, General, Stress & Holter, 50pc/p T716-50: TElectrode, 43mm x 45mm Oval, PE Foam, General, Stress & Holter, 50pc/pouch, 20 pouches/box, 1,000 pcs per Master Case

Device Class :

Duns Number: 789127011

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

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