AccessGUDID - DEVICE: Quickie® Mid-Wheel Drive Power Wheelchair (05022408052363)

GUDID

Device Identifier (DI) Information

Brand Name: Quickie® Mid-Wheel Drive Power Wheelchair
Version or Model: EIPW11
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EIPW11
Company Name: SUNRISE MEDICAL (US) LLC

Primary DI Number: 05022408052363
Issuing Agency: GS1
Commercial Distribution End Date: May 03, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 962525056 *Terms of Use

Device Description: QM-7 Series Power Wheelchair

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
41877	Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible	A 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 are performed by the occupant of the device. The device cannot be folded or readily dismantled for transport.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
ITI	Wheelchair, powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K083249	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 02feb57a-4d7c-44a2-9128-32b1ba152a71
Public Version Date: November 30, 2021
Public Version Number: 4
DI Record Publish Date: August 23, 2016