FDA.reportPublic FDA data

Merlexi Craft

Primary DI
00860000595414
Brand
Merlexi Craft
Company
Turbo Wheelchair Company, Inc.
Model
Merlexi Craft Bariatric
Device description
Plastic manual wheelchair, for bariatric users up to 425 pounds.
Published
2024-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
IORWheelchair, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IORWheelchair, MechanicalPhysical Medicine1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240120000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240120000Merlexi Craft Bariatric series of manual wheelchairsTurbo Wheelchair Co., Inc.2024-07-05IOR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860000595414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860000595414008600005954148600005954140860000595414

GMDN Terms#

Term, Definition table
TermDefinition
Push-rim manual wheelchair, bariatricA non-powered wheeled personal mobility device with an oversized seat designed to enable a bariatric person 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.

Contacts#

Phone, Email table
PhoneEmail
5026148032merlinchair@gmail.com

Regulatory Flags#

DUNS number
872623848
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860000595407Merlexi Craftmerlexi craft wheelchair2022-04-20

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Primary DI, Brand, Company table
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