FDA.report

Quickie® Series Manual Wheelchair

Primary DI
05022408048953
Brand
Quickie® Series Manual Wheelchair
Company
SUNRISE MEDICAL (US) LLC
Model
ElZ4-2
Catalog number
ElZ4-2
Device description
Quickie IRIS Manual Wheelchair
Published
2016-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
IORWHEELCHAIR, MECHANICAL

Product Code Classifications

CodeDeviceSpecialtyClass
IORWheelchair, MechanicalPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05022408048953PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05022408048953050224080489535022408048953

GMDN Terms

TermDefinition
Wheelchair, occupant-driven, rear-wheels-operated, 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 manually propelled by the user while seated in the device. The occupant moves the device by rotating both rear wheels. The device cannot be folded or readily dismantled for transport.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)333-4000webmaster@sunmed.com

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
false
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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