AccessGUDID - DEVICE: Hi-Fortune (06973852594581)

GUDID

Device Identifier (DI) Information

Brand Name: Hi-Fortune
Version or Model: P16H
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Kunshan Hi-Fortune Health Products Co.,Ltd

Primary DI Number: 06973852594581
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 548310008 *Terms of Use

Device Description: The device is a motor-driven, and indoor transportation vehicle with the intended use to provide mobility to a disabled or an elderly person limited to a seated position.

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?
47965	Multi-terrain sports wheelchair, electric-motor-driven	A wheeled personal mobility device incorporating a seat-support system for a person with a walking disability that is propelled by power from one or more electric motor(s) for multi-/all-terrain sports use. The electronic control of speed and manual control of direction is performed by the occupant; the wheels may include caterpillar tracks. This device is designed for unlimited off-road sports use on sand, rocky terrain, grass, snow, and/or wet ground.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
ITI	Wheelchair, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K212503	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: 95127a76-f33a-4c3c-8935-da531375ba33
Public Version Date: June 01, 2022
Public Version Number: 1
DI Record Publish Date: May 24, 2022