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Korebalance Mobile
Diversified Healthcare Development, LLC · Model KB05B · UDI-DI 00858458007870
10
510(k) clearances
2
Adverse events
2
Recalls
11
Facilities
Description
The Korebalance® Mobile is designed for use by medical centers and clinics, medical and PT offices, assisted living facilities recreation centers, health and fitness clubs, universities, and professional sports teams. The Korebalance® System uses the latest in interactive technology, offering innovative high-tech balance assessment and training. Backed by over two decades of medical experience, the Korebalance® will provide you and your patients with the best possible documented neurosensory assessment and training.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2009-07-24 | Neuro Kinetics | Marketed without a 510k or PMA submission to include the normative data display. |
| 2008-07-09 | Acacia Engineered Products LLC | The firm distributed an unapproved medical device. |
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Get your free API keyRead the docsData 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.