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510(k) Data Aggregation
K Number
K070085Device Name
BALANCE REHABILITATION UNIT (BRU)
Manufacturer
MEDICAA (URUGUAY) S.A.
Date Cleared
2007-02-26
(48 days)
Product Code
LXV
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MEDICAA (URUGUAY) S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Balance Evaluation and Rehabilitation
The Balance Rehabilitation Unit (BRUTM) is a system that enables the functional assessment and training/retraining of patients with balance disorders, vertigo or instability.
Device Description
The Balance Rehabilitation Unit (BRUTM) is composed of a static force platform, virtual reality projection goggles, a head tracker for sensing head movements, a safety frame, a harness, an accessory kit for different exercises, and a computer to generate stimuli.
The system performs a sequence of posturographies while the patient is receiving different visual stimuli (images displayed on the projection goggles). By using the different stimuli to identify the patient's weakness a tailored rehabilitation program with specific perceptual cues can be designed for each patient.
The Balance Rehabilitation Unit (BRUTM) performs an assessment of the impaired postural skills of patients through a series of posturographies with different sensory stimuli. The posturographies are performed using a forcemeasuring platform, which helps the physician evaluate the patient's performance. The sensory stimuli used with the Balance Rehabilitation Unit (BRUTM) include visual stimuli, through virtual reality projection goggles, somatosensorial stimuli, and vestibular stimuli.
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