WAVES (SWAY REFERENCED)

GUDID 03760310780166

VIRTUALIS

Biomechanical function analysis/rehabilitation software
Primary Device ID03760310780166
NIH Device Record Key60d6f654-b562-494d-9cf3-cbd5784f2eac
Commercial Distribution StatusIn Commercial Distribution
Brand NameWAVES (SWAY REFERENCED)
Version Model NumberV1.2.9
Company DUNS267153884
Company NameVIRTUALIS
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103760310780166 [Primary]

FDA Product Code

ISDExerciser, Measuring

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-26
Device Publish Date2021-11-18

Devices Manufactured by VIRTUALIS

03760310780807 - PhysioVR2023-05-12
03760310780814 - BalanceVR2023-05-12
03760310780692 - Motor Control Test2022-07-13
03760310780760 - MotionVR Research2022-07-13
03760310780302 - w_CTSIB2022-05-03
03760310780555 - StaticVR2021-12-17
03760310780548 - WalkVR2021-12-03
03760310780005 - Mirror2021-11-29

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