XRBehavior

XR HEALTH IL LTD · Model VRFR-930 (First Resort) · UDI-DI 07290016986181

ISD Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The VRFR-930 First Resort is a prescription only software application that provides virtual-reality–based measurements and exercises designed to support the self-management of stress, anxiety, and physical discomfort. The system is used with commercially available head-mounted displays.

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.