DEVICE: VRReliever (07290016986068)

Device Identifier (DI) Information

VRReliever
CB-510 (Luna)
In Commercial Distribution

XR HEALTH IL LTD
07290016986068
GS1

1
531893653 *Terms of Use
The CB-510 ("Luna") is intended to assist in the mitigation of pain, hot flashes and physical discomfort through distraction and supporting exercises, performed in a virtual reality (VR) environment using commercially available VR headsets. The CB-510 is a nonprescription device that can be used in clinical setting or at home, with or without the assistance of clinician. The CB-510 provides VR exercises and takes measurements which enables the patient and/or clinician to monitor changes over time. CB-510 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment.
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Cognitive training software A software program intended to be used with an off-the-shelf computer/tablet/smartphone to help improve a cognitive function (e.g., attention/concentration, memory, eye movement training to improve reading ability) by providing a patient with on-screen interactive sessions (e.g., text for audible reading, stimulating game-like activities); it is not intended for kinesiology-based neuromuscular rehabilitation and is not based on virtual reality. It may additionally be designed to screen for cognitive disorders, set baselines, and will typically show development (i.e., interactive). It is intended to be used at home, school, and in clinical settings.
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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

8697dbef-980c-4af8-a655-202a3cbab93c
July 20, 2021
6
June 13, 2019
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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

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No
No
No
No
No CLOSE

Customer Contact

[?]
+1 (857)990-6111
Support@vrhealthusa.com
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