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Bertec Vision Advantage

BERTEC CORPORATION · Model 97P-0037 · UDI-DI 00850017250000

HOX
10
510(k) clearances
2
Adverse events
0
Recalls
109
Facilities

Description

Bertec Vision Advantage (BVA) device is designed to measure changes in the visual acuity during head movements. It includes a laptop computer with a wireless remote controller, a wireless inertial measurement unit (IMU) that measures the 3-dimensional angles, velocities, and accelerations, and a headband. The headband holds the IMU in a small pouch, which allows tracking of the head movements. The remote controller is used to input the patient’s responses to the computer.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.