gudid
Primary ID: PD-810 (Mindset)
VRReliever (UDI PD-810 (Mindset))
Manufactured by XR HEALTH IL LTD
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for VRReliever - Primary ID PD-810 (Mindset)
Device Regulatory Overview
The VRReliever (Model/Catalog Number: PD-810 (Mindset)) is a medical device manufactured by XR HEALTH IL LTD. This product is indexed under FDA Product Code / Category Classification ISD within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- PD-810 (Mindset)
- Product Code / EMDN
- ISD
- Device Name
- The PD-810 ("Mindset") is intended to assist in relaxation and self-management of pain and physical discomfort through distraction and supporting meditation andrelaxation exercises, performed in a virtual reality (VR) environment using commercially available VR headsets. The PD-810 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. The PD-810 provides VR exercises and takes measurements which enables the patient and/or clinician to monitor changes over time.
- Database Sync Date
- 2026-08-09 09:18:17
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of VRReliever?
The registered manufacturer of record for VRReliever is XR HEALTH IL LTD.
What is the Primary UDI-DI identifier for VRReliever?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is PD-810 (Mindset).
What classification code is assigned to this device?
This device is registered under product classification code ISD.
Similar Classification Devices (ISD)
Other Devices by XR HEALTH IL LTD
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