Merlexi Craft

GUDID 00860000595407

plastic manual wheelchair, tamperproof or non-tamperproof.

TURBO WHEELCHAIR COMPANY, INC.

Wheelchair, occupant-driven, rear-wheels-operated, collapsible

• Primary Device ID: 00860000595407
• NIH Device Record Key: 96e810e1-4f77-455e-98aa-2e67576f6269
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Merlexi Craft
• Version Model Number: merlexi craft wheelchair
• Company DUNS: 872623848
• Company Name: TURBO WHEELCHAIR COMPANY, INC.
• 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: false
• Serial Number: false
• Manufacturing Date: false
• 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
GS1	00860000595407 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032731

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: 2022-04-28
• Device Publish Date: 2022-04-20