FDA.reportPublic FDA data

MiraColt Generation 4

Primary DI
G612MCE041
Brand
MiraColt Generation 4
Company
CHARIOT INNOVATIONS INC
Model
MCE104
Catalog number
MCE04
Device description
Generation 4 Equine Motion Simulator
Published
2024-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BXBExerciser, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXBExerciser, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G612MCE041PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Continuous passive motion joint exerciserA mains electricity (AC-powered) device designed to continuously move one or more joints (shoulder, elbow, wrist, hand/fingers, hip, knee, ankle, and/or feet/toes) without patient assistance during continuous passive motion (CPM) exercise therapy. It typically consists of a motorized carriage with pads and straps to hold and support the limb/digit, and an electrical control unit for the healthcare professional to set the variable range of motion and motion speed; it may additionally be intended to provide active resistance. It is typically intended to stimulate articular tissues, circulation of synovial fluid, reduce joint oedema, and provide neuromuscular and/or coordination training.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2546516497Support@chariotinnovations.com
2543072547Admin@chariotinnovations.com
2542246165sales@chariotinnovations.com

Regulatory Flags#

DUNS number
029807952
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G612MCE04SUAC1MiraColt Generation 4 SeatMCE104MCE04SUAC2024-03-26
G612MCE04SUAG1MiraColt Generation 4 SeatMCE104MCE04SUAG2024-03-26
G612MCE04SUCC1MiraColt Generation 4 SeatMCE104MCE04SUCC2024-03-26
G612MCE04SUCG1MiraColt Generation 4 SeatMCE104MCE04SUCG2024-03-26

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