FDA.reportPublic FDA data

SpineRotationVR

Primary DI
03760310780593
Brand
SpineRotationVR
Company
VIRTUALIS
Model
V1.1.5
Published
2021-11-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ISDExerciser, Measuring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISDExerciser, MeasuringPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760310780593PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760310780593037603107805933760310780593

GMDN Terms#

Term, Definition table
TermDefinition
Biomechanical function analysis/rehabilitation softwareA software package intended to be used to detect and display a patient’s physical exercise/movements/actions, and sometimes provide performance feedback, while using an interactive rehabilitation system, biomechanical function analysis system and/or kinesiology ambulatory recorder, as part of physical assessment/rehabilitation. It might be intended to function in conjunction with a motion-sensing system/device or limb-support robotic system, and may be capable of storing patient performance data.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
267153884
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760310780807PhysioVRv1.02023-05-04
03760310780814BalanceVRv1.02023-05-04
03760310780692Motor Control TestV0.9.02022-07-05
03760310780760MotionVR ResearchV0.2.12022-07-05
03760310780302w_CTSIBv1.0.42022-04-25
03760310780548WalkVRV0.0.162021-11-25
03760310780005Mirrorv1.0.12021-11-19
03760310780012Optokineticv3.0.62021-11-19
03760310780029Optical Flowv3.4.102021-11-19
03760310780036Motorway Simulationv2.3.42021-11-19
03760310780043Subjective Visual VerticalV2.3.42021-11-18
03760310780067Rod & Frame Testv2.3.42021-11-18
03760310780074Sway Referenced Visual EnvironmentV2.3.42021-11-18
03760310780104Target TrackingV2.3.42021-11-18
03760310780128Sea Simulationv1.2.92021-11-18
03760310780135Reading (Sway Referenced)v1.2.92021-11-18
03760310780142Liftv1.2.92021-11-19
03760310780166WAVES (SWAY REFERENCED)V1.2.92021-11-18
03760310780180Mirror & Ballv1.0.12021-11-19
03760310780203Supermarketv1.5.82021-11-18

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Primary DI, Brand, Company table
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00850000967649SpiroFitCMI HEALTH INC.ISD2026-03-06
00853858006522EmbraceMiniEMPATICA SRLISD2026-02-16
00853858006713EmbraceMiniEMPATICA SRLISD2026-02-16
07290016986174XRBehaviorXR HEALTH IL LTDISD2026-01-26
07290016986181XRBehaviorXR HEALTH IL LTDISD2026-01-26
00860014763700Aspire MotionSurge Motion Inc.ISD2025-11-14
G186EXERSCAN30Exer ScanExer Labs, Inc.ISD2025-11-10
00860004615606XR Therapy SystemNeuromersive, Inc.ISD2025-10-25
00810188050045Bioness Integrated Therapy System, BITS 3.0, BITS BalanceBioness Medical, Inc.ISD2025-07-18
00616784050218Pedal Exerciser, Folding, Digital, Hands/FeetDynarex CorporationISD2025-05-29
00850064651102DS6Foresite Healthcare, LLCISD2025-02-07
G741WHREHABV10Waya RehabWELLOVATE, LLCISD2025-02-03
00860010613320StrideLink MercuryStrideLink Inc.ISD2024-12-16
G186EXERSCAN20Exer ScanExer Labs, Inc.ISD2024-09-03
00850067173007Opal V2CAPDM WEARABLE TECHNOLOGIES, INC.ISD2024-08-30
00850067173014Docking Station V2CAPDM WEARABLE TECHNOLOGIES, INC.ISD2024-08-30
00850067173021Access Point V2CAPDM WEARABLE TECHNOLOGIES, INC.ISD2024-08-30
00850067173038Opal DataHub V2CAPDM WEARABLE TECHNOLOGIES, INC.ISD2024-08-30
00850064651003DS5Foresite Healthcare, LLCISD2024-05-24
00850064651010DS6Foresite Healthcare, LLCISD2024-05-24
00850064651027MDSForesite Healthcare, LLCISD2024-05-24
00850064651041DS6Foresite Healthcare, LLCISD2024-05-24
00850064651058DS6Foresite Healthcare, LLCISD2024-05-24
00850064651065DS6Foresite Healthcare, LLCISD2024-05-24
00815948029460REAL y-SeriesPENUMBRA, INC.ISD2024-04-16
00815948029477REAL y-SeriesPENUMBRA, INC.ISD2024-04-16
00815948029484REAL y-SeriesPENUMBRA, INC.ISD2024-04-16