MiraColt Generation 4 Seat

Basic Information

• Brand Name: MiraColt Generation 4 Seat
• Primary DI: G612MCE04SUAC1
• Version / Model: MCE104
• Catalog Number: MCE04SUAC
• Company Name: CHARIOT INNOVATIONS INC
• Labeler DUNS: 029807952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-26
• Public Version: 1
• Public Version Date: 2024-04-03
• Public Version Status: New
• Public Device Record Key: c5dbde17-b537-42e3-84bf-3de83bb6f53d

Device Description

Generation 4 Adult Seat - Cinnamon

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BXB	Exerciser, Powered	Physical Medicine	890.5380	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35059	Core body stabilization/exercise stool	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G612MCE04SUAC1	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]