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SaeboRejoyce
SAEBO, INC. · Model SaeboRejoyce · UDI-DI 00850331006567
10
510(k) clearances
47
Adverse events
4
Recalls
57
Facilities
Description
Virtual-display arm rehabilitation system
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-05-31 | Trexo Robotics Holdings Inc. | Electrical issues that could potentially render the device non-functional, give off electromagnetic influence to surrounding equipment, and risk of burns when in use. |
| 2020-06-08 | Hocoma AG | The motor controller may fail, which can potentially lead to an error in functionality of the Body Weights Support Rope, which means that the rope can go up or down in an uncontrol |
| 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. |
| 2012-05-05 | Interactive Motion Technologies, Inc. | Unsupervised patient could potentially mis-use the device and remove or rotate a protective cover and expose a potential pinch hazard. |
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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.