EnGauge Physical Rehabilitation System

Primary DI
00860008232304
Brand
EnGauge Physical Rehabilitation System
Company
Verity Technologies, Inc.
Model
VXRE-01
Device description
Verity XR EnGauge Physical Rehabilitation System is an Extended Reality software platform that augments physical rehabilitation through exercise gamification incorporating biofeedback, kinematic data reporting, and immersive learning. The EnGauge Physical Rehabilitation System software readily integrates with existing Extended Reality hardware and peripherals to provide an integrated physical rehabilitation system.
Published
2022-08-10
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
00860008232304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008232304008600082323048600082323040860008232304

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

Contacts#

Phone, Email table
PhoneEmail
630.886.4072ampatel76@gmail.com

Regulatory Flags#

DUNS number
116990338
Device count
1
Premarket exempt
true
Serial number
true

Other Devices Sharing Product Codes#

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05391548420005VertigeniusDIGITAL REHABILITATION LIMITEDQKC2025-02-23
05391548420012VertigeniusDIGITAL REHABILITATION LIMITEDQKC2025-02-23
05391548420029VertigeniusDIGITAL REHABILITATION LIMITEDQKC2025-02-20
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05065012458114Reality DTxSTROLLL LIMITEDQKC2024-07-08
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08809970060005EverEx RehabEverExQKC2024-04-03
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G186EXERHEALTH20Exer HealthExer Labs, Inc.QKC2023-03-21
G186EXERPHYSIO20Exer PhysioExer Labs, Inc.QKC2022-01-04