AccessGUDID - DEVICE: STRONGBACK (07640176290923)

GUDID

Device Identifier (DI) Information

Brand Name: STRONGBACK
Version or Model: 1036+AB/053
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: STRONGBACK MOBILITY USA, LLC

Primary DI Number: 07640176290923
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040262426 *Terms of Use

Device Description: - Self-proppelled wheelchair - Seat width: 22”/55 cm - Drum brakes - Quick release rear wheel: 24”/61 cm - Solid armrests

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":	No
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?
66679	Push-rim manual wheelchair, bariatric	A non-powered wheeled personal mobility device with an oversized seat designed to enable a bariatric person without the full capacity to walk to self-mobilize by pushing specially designed rims on the wheels while seated. It is designed with a pair of larger wheels with push-rims attached whereby the occupant propels the device by rotating both wheels; it typically includes rear-fitted handles designed for optional pushing by an attendant. It provides no function outside of wheeled mobilization.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IOR	Wheelchair, Mechanical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 3fec11e1-44b7-4dfb-b090-0b7e7c103fb2
Public Version Date: January 25, 2024
Public Version Number: 1
DI Record Publish Date: January 17, 2024