Compliance
XRHealth R&D Ltd. has established a quality management system (QMS) that indicates a commitment to quality and gives an assurance that its services and products are safe, accurate and effective, meet customer requirements, and comply with all applicable standards and regulations. XRHealth R&D Ltd. is accredited for the EN ISO-13485:2016 AND ISO-27001:2022 standards by SII, the Standard Institution of Israel. It also complies with the requirements of the US FDA 21 CFR Part 820 (QSR), to those of the Australian Therapeutic Goods Administration (TGA) and is further audited on a regular basis by customers and interested parties.
XRHealth R&D Ltd compliance obligations in terms of information security include, in addition to the ISO 27001:2022 accreditation, the Health Insurance Portability and Accountability Act (HIPAA) which addresses various security and privacy aspects in managing Protected Health Information (PHI) of US residents, the EU General Data Protection Regulation (GDPR) which addresses various security aspects in managing protected Personally Identified Information (PII) and the Privacy Low of Israel.






Regulatory Certifications
Global
USA
- FDA-Registered
- Billable as DME under PDAC-verified CMS code E1905
- HIPAA Full-stack platform
Canada
- Class II Medical Device
Australia
- TGA-Registered
- NDIS-Registered Provider
Israel
- AMAR-Registered

Approved Device List
Recommended XRHealth List
Meta Quest 2, by Meta V.79 and above
Manufacturer’s instructions
Meta Quest 3, by Meta V.79 and above
Manufacturer’s instructions
Meta Quest 3S, by Meta V.79 and above
Manufacturer’s instructions

Product documentation
XRReliever™ PD-810 “Mindset”
Instructions For Use
XRPhysio Home™ N-140 “Rotate”
Instructions For Use
XRPhysio Home™ MT-220 “Balloon Blast”
Instructions For Use
XRReliever™ MD-710 “Relax8”
Instructions For Use
XRCogni™ MC-320 “Color Match”
Instructions For Use
XRBehavior™ VRET-910 “Expose”
Instructions For Use
XRCogni™ CT-620 “Memorize”
Instructions For Use
XRReliever™ CB-510 “Luna”
Instructions For Use
XRBehavior™ VRFR-930 “First Resort”
Instructions For Use
XRBehavior™ VRMM-920 “Mind & Motion”
Instructions For Use
XRBehavior™ VRGC-940 “GameChange”
Instructions For Use
XRCogni™ CT-630 “Koji Quest”
Instructions For Use
Please contact us at info@xr.health if you would like to receive a paper version of these documents.
Fill out the form and we will get in touch.
