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Bertec Head Mounted Display System (HMD)
BERTEC CORPORATION · Model 97P-0109 · UDI-DI 00850017250116
10
510(k) clearances
35
Adverse events
2
Recalls
76
Facilities
Description
Bertec Balance Advantage Head Mounted Display (HMD) system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate with Head Mounted Display (HMD) to enhance clinical balance assessment and training.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-04-09 | BTE Technologies, Inc. | On the Primus that includes the optional Chop / Lift Bar, there is a remote possibility that the Chop / Lift Bar could get accidently detached from the snap hook in specific use sc |
| 2013-12-03 | MedX Holdings, Inc. | Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing. |
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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.