BERTEC CORPORATION

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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

Platform, Force-Measuring (KHX) (7) Chart, Visual Acuity (HOX) (1) Computerized Cognitive Assessment Aid, Exempt (PTY) (1) System, Isokinetic Testing And Evaluation (IKK) (1)

Premarket Exempt

Yes

Clear

Bertec Vision Advantage - 00850017250000 Catalog Number :

Device Description : Bertec Vision Advantage (BVA) device is designed to measure changes in the visua

Device Class : 1

Duns Number: 619142540

Premarket Exempt : Yes

Product Code : HOX

Prescription Use : No

Device Count : 1

Balance Advantage Tender Essential System - 00850017250017 Catalog Number :

Device Description : Bertec Balance Advantage Tender Essential system is a clinical balance assessmen

Device Class : 1

Duns Number: 619142540

Premarket Exempt : Yes

Product Code : KHX

Prescription Use : No

Device Count : 1

Balance Advantage Portable Functional System - 00850017250024 Catalog Number :

Device Description : Bertec Balance Advantage Portable Functional system is a clinical balance assess

Device Class : 1

Duns Number: 619142540

Premarket Exempt : Yes

Product Code : KHX

Prescription Use : No

Device Count : 1

Balance Advantage Functional System - 00850017250031 Catalog Number :

Device Description : Bertec Balance Advantage Functional system is a clinical balance assessment devi

Device Class : 1

Duns Number: 619142540

Premarket Exempt : Yes

Product Code : KHX

Prescription Use : No

Device Count : 1

Balance Advantage Essential System - 00850017250048 Catalog Number :

Device Description : Bertec Balance Advantage Essential system is a clinical balance assessment devic

Device Class : 1

Duns Number: 619142540

Premarket Exempt : Yes

Product Code : KHX

Prescription Use : No

Device Count : 1

Balance Advantage Portable essential System - 00850017250055 Catalog Number :

Device Description : Bertec Balance Advantage Portable Essential system is a clinical balance assessm

Device Class : 1

Duns Number: 619142540

Premarket Exempt : Yes

Product Code : KHX

Prescription Use : No

Device Count : 1

Balance Advantage Prime IVR System - 00850017250062 Catalog Number :

Device Description : Bertec Balance Advantage Prime IVR system is a clinical balance assessment devic

Device Class : 1

Duns Number: 619142540

Premarket Exempt : Yes

Product Code : KHX

Prescription Use : No

Device Count : 1

Balance Advantage Computerized Dynamic Posturography System - 00850017250079 Catalog Number :

Device Description : The Computerized Dynamic Posturography (CDP ) system is a clinical balance asses

Device Class : 1

Duns Number: 619142540

Premarket Exempt : Yes

Product Code : KHX

Prescription Use : No

Device Count : 1

Bertec Vision Trainer System (BVT) - 00850017250093 Catalog Number : 95P-0014

Device Description : The Bertec Vision Trainer System (BVT) is a device that objectively measures the

Device Class : 2

Duns Number: 619142540

Premarket Exempt : Yes

Product Code : IKK, PTY

Prescription Use : Yes

Device Count : 1

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