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510(k) Data Aggregation
K Number
K070676Device Name
KOREBALANCE (KINESTHETIC ABILITY TRAINER)
Manufacturer
SPORTKAT, LLC
Date Cleared
2007-04-18
(37 days)
Product Code
LXV
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SPORTKAT, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Korebalance™ device is intended for use in balance therapy, only by health care professionals with experience in balance therapy. Patient suitability must be judged by the health professional on a case by case basis.
Device Description
The updated Korebalance™ Kinesthetic Ability Trainer device has the same intended use and incorporates the same balance board (platform) and bladder design technology as the originally cleared device. The modifications are primarily software based and allow:
- 1. Creation of a patient specific electronic record of patient information via a touchscreen GUI.
- Quantitative measurement of patient balance performance while the patient 2. executes a preprogrammed set of maneuvers or protocols with the board. The GUI provides instructions and visual feedback to the patient with regard to the maneuvers to be made and the success in executing the maneuver. The patient results are scored and saved (the information is not a clinical measurement but provides a reproducible quantitative measurement that the therapist can use to plan and monitor therapy) along with the bladder pressure measurement for use by the therapist, in conjunction with the therapist's observations, to assess patient progress over the course of multiple therapy sessions. Specific protocols are provided for vestibular training, orthopedic therapy, and falls prevention. These protocols are similar to those used with the previously cleared device.
- 3. Patients to play "games" displayed on the GUI that involve performing various maneuvers on the balance platform. Performance is scored. The games provide an additional means for the therapist to provide rehabilitation that is fun and challenging for patients.
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