DEVICE: VRReliever (07290016986136)

Device Identifier (DI) Information

VRReliever
PD-810 (Mindset)
In Commercial Distribution
VRReliever PD-810
XR HEALTH IL LTD
07290016986136
GS1

1
531893653 *Terms of Use
The PD-810 ("Mindset") is intended to assist in relaxation and self-management of pain and physical discomfort through distraction and supporting meditation and relaxation exercises, performed in a virtual reality (VR) environment using commercially available VR headsets. The PD-810 is a nonprescription 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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Hypnotherapy virtual reality software A virtual reality software program intended to be used with an appropriate off-the-shelf device in conjunction with a virtual reality headset (not included) to help reduce stress/anxiety by providing a patient with immersive imagery/sounds for relaxation hypnosis. It may be intended to sedate a patient or assist pain therapies. It is not intended to treat affective/mood disorders. It is intended to be used by patients in clinical settings, or at home under clinician consultation.
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FDA Product Code

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Product Code Product Code Name
ISD Exerciser, Measuring
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

0fd29e16-ec83-40b5-b43d-23e117e3c404
July 20, 2021
3
June 15, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
+1 (857)-990-6111
support@xr.health
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