FS-Series Wheelchair

GUDID 06938001014426

MECHANICAL WHEELCHAIR

FOSHAN DONGFANG MEDICAL EQUIPMENT MANUFACTORY (LTD.)

Push-rim manual wheelchair, non-bariatric

• Primary Device ID: 06938001014426
• NIH Device Record Key: a8040e0b-151d-453e-8e85-b019998a5760
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FS-Series Wheelchair
• Version Model Number: FS804LABJF3
• Company DUNS: 531127793
• Company Name: FOSHAN DONGFANG MEDICAL EQUIPMENT MANUFACTORY (LTD.)
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06938001014426 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041814

FDA Product Code

• IOR: Wheelchair, Mechanical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-10
• Device Publish Date: 2026-02-02

On-Brand Devices [FS-Series Wheelchair]

• 06938001012187: MECHANICAL WHEELCHAIR
• 06938001011944: MECHANICAL WHEELCHAIR
• 06938001011920: MECHANICAL WHEELCHAIR
• 06938001011524: MECHANICAL WHEELCHAIR
• 06938001011470: MECHANICAL WHEELCHAIR
• 06938001010664: MECHANICAL WHEELCHAIR
• 06938001010220: MECHANICAL WHEELCHAIR
• 06938001010183: MECHANICAL WHEELCHAIR
• 06938001014426: MECHANICAL WHEELCHAIR