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Leckey MyWay Size 1

FDA UDI

Class I (US FDA UDI)

by Sunrise Medical (US) LLC

Identity

Trade Name
Leckey MyWay Size 1 FDA UDI
Generic Name
Hands-free disability-assistive walker FDA UDI
Device Name
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. FDA UDI
Model / Reference
MyWay Size 1 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
05059804173019 FDA UDI
FDA Product Code
ITJ FDA UDI
GMDN Term
Hands-free disability-assistive walker FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3825 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Hands-free disability-assistive walker

Leckey MyWay Size 1 by Sunrise Medical (US) LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hands-free disability-assistive walker.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sunrise Medical (US) LLC

Sources (1)

  • FDA UDI 99dcac32-d7b3-41aa-8c0e-46c3715aba4e 33 fields · synced Jun 9, 2026