FOLD & GO Wheelchairs

GUDID G450ARK5500

Onekubed Designs LLC

Electric-motor-driven wheelchair, occupant-controlled

• Primary Device ID: G450ARK5500
• NIH Device Record Key: ebbfd710-c099-4ae7-87dd-bb431572a1e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FOLD & GO Wheelchairs
• Version Model Number: Ark550®
• Company DUNS: 099823918
• Company Name: Onekubed Designs LLC
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G450ARK5500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170787

FDA Product Code

• ITI: Wheelchair, Powered

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: 2026-03-09
• Device Publish Date: 2026-02-27

On-Brand Devices [FOLD & GO Wheelchairs]

• G450MAGSHOCK00: WeatherPROOF Magnesium Frame Electric Wheelchairs, Weight Capacity up to 400 lbs, Hill Climb up
• G450ARK5500: Ark550®