FDA.reportPublic FDA data

WOTURE

Primary DI
B845X3013
Brand
WOTURE
Company
Intco Medical Industries, Inc.
Model
X301
Device description
This is suitable for a single user with limited mobility. It is suitable for indoor and outdoor use. The purpose of walking devices is to compensate for or at least improve restricted walking ability in users.
Published
2025-06-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITJWalker, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITJWalker, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B845X3013PackageHIBCC1In Commercial Distribution
B845X3011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Walker trayA metal or plastic platform designed to be attached to a wheeled walker upon which a user may place objects or perform an activity.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+862134978818maxli@intco.com

Regulatory Flags#

DUNS number
080162537
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B845FM301A501BASICFM301A502024-06-14
B845X1021WOTUREX1022025-08-20
B845X1023WOTUREX1022025-08-20
B845X3011WOTUREX3012025-06-13
B845X3021WOTUREX3022025-06-13
B845X3023WOTUREX3022025-06-13
B845FM301A50K1BASICFM301A50K2025-04-30
B845FM301A50W1BASICFM301A50W2025-04-30
B845FM301A50K3BASICFM301A50K2025-04-30
B845FM301A50W3BASICFM301A50W2025-04-30
B845CBZ0411WOTURECBZ0412025-03-28
B845CBZ0413WOTURECBZ0412025-03-28
B845CBZ041WOTURECBZ042025-03-20
B845NGPF201C31BASICNGPF201C3NGPF201C32024-09-28
B845NGPF201C41BASICNGPF201C4NGPF201C42024-09-28
B845NGPF201C51BASICNGPF201C5NGPF201C52024-09-28
B845NGPF201C61BASICNGPF201C6NGPF201C62024-09-28
B845NGPF201C71BASICNGPF201C7NGPF201C72024-09-28
B845NGPF201C81BASICNGPF201C8NGPF201C82024-09-28
B845NGPF203C31BASICNGPF203C3NGPF203C32024-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06977176610255BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
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06977176610286BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
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06977176610323BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610330BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610347BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610354BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
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06977176610408BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
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06977176610422BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610439BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610446BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610453BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
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