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) (4) Joint, Knee, External Brace (ITQ) (1) Orthosis, Cervical (IQK) (1) Orthosis, Foot Drop (OHI) (1) Oximeter (DQA) (1) Oximeter, Infrared, Sporting, Aviation (OCH) (1) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (1)

Premarket Exempt

No Yes

Clear

ViveSole - 00081004198931 Catalog Number :

Device Description : Gel Metatarsal Sleeve

Device Class : 1

Duns Number: 047025993

Premarket Exempt : Yes

Product Code : OHI

Prescription Use : No

Device Count : 1

VIVE - 00081832302067 Catalog Number :

Device Description : Elbow Brace Rebrand

Device Class : 1

Duns Number: 047025993

Premarket Exempt : Yes

Product Code : ITQ

Prescription Use : No

Device Count : 1

Vive Presicion - 00081832302159 Catalog Number :

Device Description : Pulse Oximeter White

Device Class : 2

Duns Number: 047025993

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

VIVE - 00810041980007 Catalog Number :

Device Description : CPAP Pillow

Device Class : 1

Duns Number: 047025993

Premarket Exempt : Yes

Product Code : IQK

Prescription Use : No

Device Count : 1

VIVE - 00810041980038 Catalog Number :

Device Description : Bluetooth Pulse Oximeter

Device Class : 2

Duns Number: 047025993

Premarket Exempt : Yes

Product Code : OCH

Prescription Use : No

Device Count : 1

VIVE - 00810041980168 Catalog Number :

Device Description : Blood Pressure Monitor for Smart Devices

Device Class : 2

Duns Number: 047025993

Premarket Exempt : Yes

Product Code : DXN

Prescription Use : No

Device Count : 1

CoreTech - 00810041980335 Catalog Number :

Device Description : Standard Pneumatic Walker Black (Small)

Device Class : 1

Duns Number: 047025993

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

CoreTech - 00810041980342 Catalog Number :

Device Description : Standard Pneumatic Walker Black (Medium)

Device Class : 1

Duns Number: 047025993

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

CoreTech - 00810041980359 Catalog Number :

Device Description : Standard Pneumatic Walker Black (Large)

Device Class : 1

Duns Number: 047025993

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

CoreTech - 00810041980366 Catalog Number :

Device Description : Standard Pneumatic Walker Black (XL)

Device Class : 1

Duns Number: 047025993

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

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