VIVE HEALTH LLC

Address:8955 Fontana Del Sol Way,Naples,FL,34109,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

Joint, Ankle, External Brace (ITW) (7) Band Or Belt, Pelvic Support (ISR) (3)

Premarket Exempt

No Yes

Clear

CoreTech - 00810041980526 Catalog Number :

Device Description : Tall Pneumatic Walking Boot (Black) (Medium)

Device Class : 1

Duns Number: 047025993

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

CoreTech - 00810041980571 Catalog Number :

Device Description : Tall Pneumatic Walking Boot (Black) (Large)

Device Class : 1

Duns Number: 047025993

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

CoreTech - 00810041980601 Catalog Number :

Device Description : Tall Pneumatic Walking Boot (Black) (XL)

Device Class : 1

Duns Number: 047025993

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

CoreTech - 00810041980991 Catalog Number :

Device Description : Short Pneumatic Walking Boot (Black) (Medium)

Device Class : 1

Duns Number: 047025993

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

VIVE - 00810041981004 Catalog Number :

Device Description : LSO Back Brace

Device Class : 1

Duns Number: 047025993

Premarket Exempt : Yes

Product Code : ISR

Prescription Use : No

Device Count : 1

VIVE - 00810041981011 Catalog Number :

Device Description : LSO Back Brace

Device Class : 1

Duns Number: 047025993

Premarket Exempt : Yes

Product Code : ISR

Prescription Use : No

Device Count : 1

VIVE - 00810041981028 Catalog Number :

Device Description : 8" Lumbar Back Brace

Device Class : 1

Duns Number: 047025993

Premarket Exempt : Yes

Product Code : ISR

Prescription Use : No

Device Count : 1

VIVE - 00810041981035 Catalog Number :

Device Description : Tall Pneumatic Walking Boot

Device Class : 1

Duns Number: 047025993

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

VIVE - 00810041981042 Catalog Number :

Device Description : Short Pneumatic Walking Boot

Device Class : 1

Duns Number: 047025993

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

VIVE - 00810041981080 Catalog Number :

Device Description : 4386 Standard Walker Boot

Device Class : 1

Duns Number: 047025993

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

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