Duns Number:531893653
Device Description: The CB-510 ("Luna") is intended to assist in the mitigation of pain, hot flashes and physi 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 prescription-only 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.
Catalog Number
-
Brand Name
VRReliever
Version/Model Number
CB-510 (Luna)
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ISD
Product Code Name
Exerciser, Measuring
Public Device Record Key
8697dbef-980c-4af8-a655-202a3cbab93c
Public Version Date
September 16, 2022
Public Version Number
8
DI Record Publish Date
June 13, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |