AccessGUDID - DEVICE: FS-Series Wheelchair (06938001010183)

GUDID

Device Identifier (DI) Information

Brand Name: FS-Series Wheelchair
Version or Model: FS958LBHP
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FOSHAN DONGFANG MEDICAL EQUIPMENT MANUFACTORY (LTD.)

Primary DI Number: 06938001010183
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 531127793 *Terms of Use

Device Description: MECHANICAL 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":	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?
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 [?]
K041814	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: 26f112cb-a1fa-4bcd-b5f8-0d19b84671f9
Public Version Date: January 21, 2025
Public Version Number: 1
DI Record Publish Date: January 13, 2025