XRBehavior

XR HEALTH IL LTD · Model VRMM-920 (Mind&Motion) · UDI-DI 07290016986174

ISD Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The XRBehavior VRMM-920 ("Mind&Motion") is a prescription only software as medical device. The software provides programmed exercises within a gamified three-dimensional VR environment to teach patients self-management behaviors of the physical sensation of pain or discomfort, or to distract a patient from the physical sensation of pain or discomfort.

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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Data 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.