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, Cutaneous (GXY) (4) Electrode, Electrocardiograph (DRX) (4) Interferential Current Therapy (LIH) (1) Stimulator, Nerve, Transcutaneous, For Pain Relief (GZJ) (1)

Premarket Exempt

No Yes

Clear

Bio Protech - 00817120020555 Catalog Number :

Device Description : PT2334 Resting Tabs- 23x34mm Resting ECG Tabs (5,000 pcs in Master Case/ 25,000 PT2334 Resting Tabs- 23x34mm Resting ECG Tabs (5,000 pcs in Master Case/ 25,000 pcs in a Full Master Carton).

Device Class :

Duns Number: 789127011

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020562 Catalog Number :

Device Description : MaxTens 1k - Analog Tens Unit, with Black Carrying Case

Device Class : 2

Duns Number: 789127011

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020579 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 - 00817120020586 Catalog Number :

Device Description : PT2334 Resting Tabs No Logo- 23x34mm Resting ECG Tabs, with No Logo on Product ( PT2334 Resting Tabs No Logo- 23x34mm Resting ECG Tabs, with No Logo on Product (5,000 pcs in Master Case).

Device Class : 2

Duns Number: 789127011

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020593 Catalog Number :

Device Description : PT2334 Resting Tabs SJS- 23x34mm Resting ECG Tabs, SJS, (5,000 pcs in Master Case).

Device Class : 2

Duns Number: 789127011

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020616 Catalog Number :

Device Description : 4848 TSBA - 48x48 mm Square (2x2in Sq.) Tricot Silver Backing Tens Electrodes, 4848 TSBA - 48x48 mm Square (2x2in Sq.) Tricot Silver Backing Tens Electrodes, with Aluminum pouches.

Device Class : 2

Duns Number: 789127011

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020623 Catalog Number :

Device Description : 48R TSBA - 48rdmm (2in round) Tricot Silver Backing Tens Electrodes, with Alumi 48R TSBA - 48rdmm (2in round) Tricot Silver Backing Tens Electrodes, with Aluminum pouches.

Device Class : 2

Duns Number: 789127011

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020630 Catalog Number :

Device Description : RG02 TSBA - 90x50mm Rectangle (2x4in Rectangle) Tricot Silver Backing Tens Elec RG02 TSBA - 90x50mm Rectangle (2x4in Rectangle) Tricot Silver Backing Tens Electrodes, with Aluminum pouches.

Device Class : 2

Duns Number: 789127011

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020647 Catalog Number :

Device Description : T716-5S: TElectrode, 43mm x 45mm Oval, PE Foam, General, Stress & Holter, 5 pc S T716-5S: TElectrode, 43mm x 45mm Oval, PE Foam, General, Stress & Holter, 5 pc Strip, 20 pouches/box, 10 boxes/ case, 1,000 pcs per master case(5 Piece ECG on a Strip in each pouch).

Device Class : 2

Duns Number: 789127011

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020654 Catalog Number :

Device Description : 30RdTSBA- 30mm Round Tricot Elite Silver Backing Tens Electrodes, with Aluminum 30RdTSBA- 30mm Round Tricot Elite Silver Backing Tens Electrodes, with Aluminum pouches.

Device Class : 2

Duns Number: 789127011

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

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