AccessGUDID - DEVICE: Elevation Ultralight Manual Wheelchair (B829201)

GUDID

Device Identifier (DI) Information

Brand Name: Elevation Ultralight Manual Wheelchair
Version or Model: ELEVATION
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5520
Company Name: PDG Product Design Group Inc

Primary DI Number: B829201
Issuing Agency: HIBCC
Commercial Distribution End Date: August 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 253873905 *Terms of Use

Device Description: No description.

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):	No
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?
41512	Push-rim manual wheelchair, non-bariatric	A non-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or 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 [?]
K140023	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: a76327ba-905c-4df9-9a6a-3461cdcdf272
Public Version Date: November 25, 2025
Public Version Number: 2
DI Record Publish Date: September 28, 2020