iWALK3.0, the iWALKFree 3.0 Hands Free Crutch

Primary DI
00860002590813
Brand
iWALK3.0, the iWALKFree 3.0 Hands Free Crutch
Company
IWALK FREE
Model
HFC30303
Device description
iWALK3.0 is a assistive mobility device most accurately described as a hands free crutch. It acts as a temporary lower leg orthotic or prosthetic and provides hands free mobility for non-weight bearing lower leg injuries. It recruits the uninjured upper leg of the user to provide ambulation.
Published
2021-03-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
IPRCrutch
IQIOrthosis, Limb Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPRCrutchPhysical Medicine1
IQIOrthosis, Limb BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860002590813PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860002590813008600025908138600025908130860002590813

GMDN Terms#

Term, Definition table
TermDefinition
Single-side-support walking frameA mobility aid in the form of a waist-high framework and a handgrip with two legs designed to provide a stable support to only one side of the user, e.g., a person with a disability, a geriatric or an infirm person; it may also be used during rehabilitation. It is typically constructed of lightweight metal, plastic and rubber materials in the shape of an "A" or and inverted "U" frame with a cross-strut or struts that keep the two feet apart providing stable contact with the ground. It is held by the user's hand to provide an optional form of support for standing and ambulating for a user needing more support than that provided by a walking stick (a cane) and who do not require a crutch.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079461204
Device count
1
Premarket exempt
true
Serial number
true

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Primary DI, Brand, Company table
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