VRPhysio

Primary DI
07290016986099
Brand
VRPhysio
Company
XR HEALTH IL LTD
Model
N-140 (Rotate)
Device description
A software-only medical device intended for cervical region rehabilitation. The software tracks motion and movement kinematics and guides patients in the performance of physical exercises according to their treating medical practitioner's guidelines. The N-140 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. N-140 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment.
Published
2019-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
07290016986099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016986099072900169860997290016986099

GMDN Terms#

Term, Definition table
TermDefinition
Biomechanical function analysis/interactive rehabilitation systemA computerized device assembly designed for: 1) analysis of biomechanical/neuromuscular function using dedicated hardware; and 2) neuromuscular rehabilitation therapy at multiple anatomical sites based on patient interaction with dedicated physical-response measuring hardware (e.g., dynamometer, standing force plates, EMG electrodes) providing feedback in a videogame-like format. It includes multiple pieces of neuromuscular function analysis and physical-response measuring hardware, computer interface devices and dedicated software; it is intended to be used with an off-the-shelf computer. It is not based on tracking movement through space (i.e., not a virtual-display rehabilitation system).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (857)-990-6111support@xr.health

Regulatory Flags#

DUNS number
531893653
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016986211XRBehaviorVRSO-940 (Step Out)2026-05-14
07290016986204XRBehaviorVRGC-940 (GameChange)2026-05-04
07290016986198XRCogni CT-630 Koji Quest2026-02-12
07290016986174XRBehaviorVRMM-920 (Mind&Motion)2026-01-26
07290016986181XRBehaviorVRFR-930 (First Resort)2026-01-26
07290016986143VRCBTAT-910 (A10tion)VRCBT AT-9102021-06-15
07290016986129VRRelieverMD-710 (Relax8)2020-01-21
07290016986112VRCogniCT-620 (Memorize)2019-12-30
07290016986105VRCogniCT-610 (Re-Act)2019-11-28
07290016986068VRRelieverCB-510 (Luna)2019-06-13
07290016986167VRBehaviorVRET-910 (Expose)2024-04-09
07290016986075VRCogniMC-320 (Color Match)2020-02-20
07290016986082VRPhysio MT-220 (Balloon Blast)2019-09-08
07290016986006VRPhysioN-110 (Aqua Clown)2018-05-01
07290016986013VRPhysioMT-210 (Balloon Blast)2018-05-01
07290016986020VRPhysioN-120 (Catch the Screen)2018-05-01
07290016986037VRPhysioP-410 (Dot Track)2018-07-18
07290016986044VRPhysioMC-310 (Color Match)2018-07-18
07290016986136VRRelieverPD-810 (Mindset)VRReliever PD-8102021-06-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08717524641092Lode B.V.Lode B.V.ISD2026-06-01
07649998859059NUSHUMagnes AGISD2026-05-31
07290016986211XRBehaviorXR HEALTH IL LTDISD2026-05-14
07290016986204XRBehaviorXR HEALTH IL LTDISD2026-05-04
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00853858006713EmbraceMiniEMPATICA SRLISD2026-02-16
07290016986174XRBehaviorXR HEALTH IL LTDISD2026-01-26
07290016986181XRBehaviorXR HEALTH IL LTDISD2026-01-26
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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
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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