FDA.reportPublic FDA data

MiraColt Generation 4 Seat

Primary DI
G612MCE04SUAC1
Brand
MiraColt Generation 4 Seat
Company
CHARIOT INNOVATIONS INC
Model
MCE104
Catalog number
MCE04SUAC
Device description
Generation 4 Adult Seat - Cinnamon
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
G612MCE04SUAC1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Core body stabilization/exercise stoolA seat designed to be occupied by a patient during exercise or treatment, and/or to improve core body stability whilst seated, typically as part of physiotherapy or ergotherapy. It is in the form of an ergonomically-designed seating platform with no back support (i.e., not a chair) intended to facilitate muscular activation/exercise.

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
G612MCE041MiraColt Generation 4MCE104MCE042024-03-26
G612MCE04SUAG1MiraColt Generation 4 SeatMCE104MCE04SUAG2024-03-26
G612MCE04SUCC1MiraColt Generation 4 SeatMCE104MCE04SUCC2024-03-26
G612MCE04SUCG1MiraColt Generation 4 SeatMCE104MCE04SUCG2024-03-26

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