FDA.report

Quickie Q500H Series Power Chair

Primary DI
05022408058709
Brand
Quickie Q500H Series Power Chair
Company
SUNRISE MEDICAL (US) LLC
Model
5870
Catalog number
92282
Device description
Quickie Q500 hybrid drive power wheelchair
Published
2019-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ITIWheelchair, powered

Product Code Classifications

CodeDeviceSpecialtyClass
ITIWheelchair, PoweredPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05022408058709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05022408058709050224080587095022408058709

GMDN Terms

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

Regulatory Flags

DUNS number
962525056
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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