AccessGUDID - DEVICE: TUNG KENG (04719884540026)

GUDID

Device Identifier (DI) Information

Brand Name: TUNG KENG
Version or Model: Joy Rider
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TUNG KENG ENTERPRISE CO., LTD.

Primary DI Number: 04719884540026
Issuing Agency: GS1
Commercial Distribution End Date: January 17, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 656399912 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
41875	Electric-motor-driven wheelchair, occupant-controlled	An electrically-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 using power from an electric motor(s). It includes controls (typically joystick) to allow the occupant electronic control of speed/direction; it is not designed with a foot platform and handlebars (i.e., not a mobility scooter).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITI	Wheelchair, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K220156	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: 40cd37ff-eb3d-4321-a0eb-5eb5f4a64361
Public Version Date: January 09, 2025
Public Version Number: 2
DI Record Publish Date: January 18, 2024