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K-D Balance
King-Devick Test, Inc. · Model 2.0 · UDI-DI 00199874750514
1
510(k) clearances
2
Adverse events
2
Recalls
11
Facilities
Description
Software used in smart phone to determine balance
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.