BIONX MEDICAL TECHNOLOGIES, INC.

BIONX MEDICAL TECHNOLOGIES, INC.

Address:3230 Fallow Field Dr,Diamond Bar,CA,91765,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

Assembly, Knee/Shank/Ankle/Foot, External (ISW) (10)

Premarket Exempt

Yes

Clear

BiOM T2 - B1551100A0 Catalog Number :

Device Class : 2

Duns Number: 788290471

Premarket Exempt : Yes

Product Code : ISW

Prescription Use : Yes

Device Count : 1

BiOM T2 - B1551100ABLK0 Catalog Number :

Device Class : 2

Duns Number: 788290471

Premarket Exempt : Yes

Product Code : ISW

Prescription Use : Yes

Device Count : 1

BiOM T2 - B1551100ASLV0 Catalog Number :

Device Class : 2

Duns Number: 788290471

Premarket Exempt : Yes

Product Code : ISW

Prescription Use : Yes

Device Count : 1

BiOM T2 - B1551103A0 Catalog Number :

Device Description : BiOM T2 (Ankle only)

Device Class : 2

Duns Number: 788290471

Premarket Exempt : Yes

Product Code : ISW

Prescription Use : Yes

Device Count : 1

BiOM T2 - B1551103B0 Catalog Number :

Device Description : BiOM T2 Black (Ankle only)

Device Class : 2

Duns Number: 788290471

Premarket Exempt : Yes

Product Code : ISW

Prescription Use : Yes

Device Count : 1

BiOM T2 - B1551103S0 Catalog Number :

Device Description : BiOM T2 Silver (Ankle only)

Device Class : 2

Duns Number: 788290471

Premarket Exempt : Yes

Product Code : ISW

Prescription Use : Yes

Device Count : 1

BiOM T2 - B15520012190 Catalog Number :

Device Description : BiOM T2 Wireless Tuning Device

Device Class : 2

Duns Number: 788290471

Premarket Exempt : Yes

Product Code : ISW

Prescription Use : Yes

Device Count : 1

BiOM T2 - B15520015960 Catalog Number :

Device Description : BiOM T2 Battery

Device Class : 2

Duns Number: 788290471

Premarket Exempt : Yes

Product Code : ISW

Prescription Use : Yes

Device Count : 1

BiOM T2 - B15520017930 Catalog Number :

Device Description : BiOM T2 Battery Charger

Device Class : 2

Duns Number: 788290471

Premarket Exempt : Yes

Product Code : ISW

Prescription Use : Yes

Device Count : 1

emPOWER - B155EM0B0 Catalog Number :

Device Description : emPOWER Ankle System, Black

Device Class : 2

Duns Number: 788290471

Premarket Exempt : Yes

Product Code : ISW

Prescription Use : Yes

Device Count : 1

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