FDA.reportPublic FDA data

Leckey MyWay Size 3

Primary DI
05059804173033
Brand
Leckey MyWay Size 3
Company
SUNRISE MEDICAL (US) LLC
Model
MyWay Size 3
Device description
The supportive gait training walker for children which is all about providing children with maximum opportunities for interaction, exploration and participation in a supported, upright position.
Published
2023-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
05059804173033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05059804173033050598041730335059804173033

GMDN Terms#

Term, Definition table
TermDefinition
Hands-free disability-assistive walkerA non-powered wheeled mobility aid in the form of a non-foldable framework with legs designed to provide a stable hands-free support for a patient with a walking disability (e.g., due to cerebral palsy) or a geriatric/infirm patient when standing or ambulating. It is made of sturdy but lightweight materials in the shape of a mobile support structure with a rear-support mechanism which provides weight-bearing from the back of the patient (e.g., straps around the back and abdominopelvic area).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
962525056
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00016958061888JAY LITEPRO CUSHIONJLPXXYY2026-03-05
00016958057591RGKOctane2023-09-05
00016958059373RGK Octane Sub4Sub 42023-09-05
00016958060249RGK Octane FXFX2023-09-05
00016958053593Quickie QX/QXiQX/QXiEIF62021-05-04
00016958053661Quickie SR45SR45EIZ92021-05-04
00016958056761Quickie XtenderQuickie XtenderEIXT2021-05-03
00016958058413Cool Cube / TouchDrive 2CCB / TD2SWI2021-05-12
00016958058437CTRL+5, Dual Pro, Joystick in a Can, MicroGuide, MicroPilot, and Tough JoyStickSwitch-ItSWI2021-05-12
00016958050110Jay EasyEasyE2607 / E26082023-09-12
00016958050127Jay Basic BackBasic Back2023-09-12
00016958050134Jay Focus Point BackFocus Point Back2023-09-12
00016958053135Jay Encompass BackEncompass2023-09-12
00016958053647Zippie VoyageVoyage; Voyage VIPEIZ14. EIZ16, EIZ182023-09-12
00016958056563Jay Fusion Jay Flow Fluid/Jay Air/ Jay Fluid w/CryoE2622/ E2623 / E2624 / E26252023-09-12
00016958058451Switch-It MicroGuide, MicroPilot, VersaGuide, VersaGuideEZ, SWI2023-09-12
00016958059694 Xtreme X8 4WDXtreme X8EIMM2023-09-12
00016958059380EmpluseF35EISP112025-04-21
00016958059526QuickieQS5 XEIF72024-12-02
00016958059366EmpluseR20EISP92024-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536930186BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00199536930193BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00199536930209BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00199536930216BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00199536930223BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00810178885022Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885039Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885046Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885053Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885060Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885077Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885619Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178887347Vive MobilityVIVE HEALTH LLCITJ2026-04-27
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14895262504266SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504273SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504280SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504693HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504709HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504716HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504730HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
24895262504324SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
54895262504226HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
54895262504233HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
54895262504240HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
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B845X1021WOTUREIntco Medical Industries, Inc.ITJ2025-08-20
B845X3011WOTUREIntco Medical Industries, Inc.ITJ2025-06-13