FDA.reportPublic FDA data

Proactive You

Primary DI
00860011881728
Brand
Proactive You
Company
VIRTUSENSE TECHNOLOGIES, INC.
Model
1.0.3
Published
2025-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QKCInteractive Rehabilitation Exercise Device, Prescription Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKCInteractive Rehabilitation Exercise Device, Prescription UsePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011881728PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011881728008600118817288600118817280860011881728

GMDN Terms#

Term, Definition table
TermDefinition
Virtual-display rehabilitation system, non-supportive, clinicalAn assembly of devices intended to be used in a clinical setting to provide non-gravity-compensating rehabilitation therapy for neuromuscular/musculoskeletal conditions affecting the back/trunk/limbs (e.g., impaired limb function) through patient interaction with a videogame-like display prompting repeated motion of a body part (e.g., arm, hand, leg) for functional improvement; it may also provide performance feedback. It does not provide weight support and is based on motion-sensing devices [e.g., battery-powered patient-worn infrared (IR) glove, motion tracking heel pad, movement tracking camera, software] that communicate wirelessly to provide a virtual-display interface.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117239864
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011881711Proactive Strides1.0.72025-12-01
00860011881704VSTBalancev2024-01Jan-11-e940.json2024-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G693YSV10YourSteps Yoursteps Health, Inc.QKC2026-04-30
088830000113113DGaitCARECAM PTE. LTD.QKC2026-04-22
03760272650699MindMotion Toap Run NeuroXtherapeutics SAQKC2026-04-13
03760272650880MindMotion GO Procedure PackNeuroXtherapeutics SAQKC2026-03-23
03760272650774MindMotion GO Procedure PackNeuroXtherapeutics SAQKC2026-03-16
05694230564040NeckCare HomeNeckCare Holding ehfQKC2026-03-09
07290020097040Kemtai CareKEMTAI LTDQKC2026-02-05
07290020097002Kemtai CareKEMTAI LTDQKC2025-12-23
07290020097019Kemtai CareKEMTAI LTDQKC2025-12-23
07290020097026Kemtai CareKEMTAI LTDQKC2025-12-23
07290020097033Kemtai CareKEMTAI LTDQKC2025-12-23
05065012458138Strolll RehabSTROLLL LIMITEDQKC2025-12-16
00860011881711Proactive StridesVIRTUSENSE TECHNOLOGIES, INC.QKC2025-12-01
05694230564026NeckCare ExercisesNeckCare Holding ehfQKC2025-05-30
05391548420005VertigeniusDIGITAL REHABILITATION LIMITEDQKC2025-02-23
05391548420012VertigeniusDIGITAL REHABILITATION LIMITEDQKC2025-02-23
05391548420029VertigeniusDIGITAL REHABILITATION LIMITEDQKC2025-02-20
05391548420036VertigeniusDIGITAL REHABILITATION LIMITEDQKC2025-02-20
05065012458114Reality DTxSTROLLL LIMITEDQKC2024-07-08
05065012458121Reality DTxSTROLLL LIMITEDQKC2024-07-08
G629RESTORESKILLSTHERA0Restore Skills TherapyTIMOCCO USA, INC.QKC2024-06-27
00860011881704VSTBalanceVIRTUSENSE TECHNOLOGIES, INC.QKC2024-06-10
08809970060005EverEx RehabEverExQKC2024-04-03
00196852042524Motion TrainerTrainer Rx, Inc. D/B/A RecoveryoneQKC2023-08-29
05065012458039Reality DTxSTROLLL LIMITEDQKC2023-08-22
05065012458046Reality DTxSTROLLL LIMITEDQKC2023-08-22
05065010464001GaitSmart®DYNAMIC METRICS LIMITEDQKC2023-05-17
G186EXERHEALTH20Exer HealthExer Labs, Inc.QKC2023-03-21
00860008232304EnGauge Physical Rehabilitation SystemVerity Technologies, Inc.QKC2022-08-10
G186EXERPHYSIO20Exer PhysioExer Labs, Inc.QKC2022-01-04