FDA.reportPublic FDA data

TRZ-CG POWER POSITIONING SYSTEM

Primary DI
00754014710966
Brand
TRZ-CG POWER POSITIONING SYSTEM
Company
Motion Concepts Inc
Model
55T-RPSB-MAXX
Device description
MCT SEAT - MAXX RAIL
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITIWheelchair, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITIWheelchair, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00754014710966PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00754014710966007540147109667540147109660754014710966

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, non-collapsibleA wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be propelled by power from one or more electric motor(s). The electronic control of speed and direction may be performed by an attendant or the occupant. The device cannot be folded or readily dismantled for transport.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
905-695-0134info@motionconcepts.com

Regulatory Flags#

DUNS number
259777209
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540147001261Matrx Elite Back Interface Kit for Permobil Tilt/ReclinePERMMHPERMMH2022-12-08
07540147001278Matrx Elite Back Interface Kit for Quantum Tilt/ReclineQUANMHQUANMH2022-12-08
07540147001285Matrx Elite Back Interface Kit for Quickie Tilt/ReclineQUIKMHQUIKMH2022-12-08
07540147001292Matrx E2 Back Interface Kit for Permobil Tilt/ReclinePERMMH-E2PERMMH-E22022-12-08
07540147001308Matrx E2 Back Interface Kit for Quantum Tilt/ReclineQUANMH-E2QUANMH-E22022-12-08
07540147001315Matrx E2 Back Interface Kit for Quickie Tilt/ReclineQUIKMH-E2QUIKMH-E22022-12-08
07540147001599Tilt-Only Straight Back CanesD-0124-SBCSBC2022-12-08
07540147001605Tilt-Only Angled Back Canes (5°)D-0124-ABCABC2022-12-08
07540147001612Tilt-Only Endomorph Back CanesD-0124-EBCEBC2022-12-08
07540147001629Tilt-Only Mid-Angle Back Canes (10°)D-0124-TBCTBC2022-12-08
07540147001643Adult Mesomorph Tilt Back CanesD-0124-MBCAMBCA2022-12-08
07540147001650Med-Adult Tilt-Only Straight Back CanesD-0124-SBCMASBCMA2022-12-08
07540147001667Med-Adult Tilt-Only Angled (5°) Back CanesD-0124-ABCMAABCMA2022-12-08
07540147001674Med-Adult Tilt-Only Mid-Angle (10°) Back CanesD-0124-TBCMATBCMA2022-12-08
07540147001681Mini Tilt-Only Straight Back CanesD-0124-SBCMSBCM2022-12-08
07540147001698Fold-Down Back Cane Kit (Pull-Pin)D-0124-FDBCFDBC2022-12-08
07540147001933Freedom Back Interface (Tilt-Only)D-0139-FBITFBIT2022-12-08
07540147001940Freedom Back Interface (Recline)D-0139-FBIRFBIR2022-12-08
07540147001957Freedom Seat Interface Plate (Seat Pan)D-0139-FSIPFSIP2022-12-08
07540147001964Maces Interface Assy, Ride Style Back (Recline)D-0139-RSMIRSMI2022-12-08

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Primary DI, Brand, Company table
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