FDA.reportPublic FDA data

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
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
IQIOrthosis, Limb Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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 Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840194499194Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499200Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499217Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499224Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499231Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499248Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499255Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499262Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499279Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00645517899350TrulifeTRULIFE LIMITEDIQI2026-02-17
00645517899367TrulifeTRULIFE LIMITEDIQI2026-02-17
00645517899374TrulifeTRULIFE LIMITEDIQI2026-02-17
00645517899381TrulifeTRULIFE LIMITEDIQI2026-02-17
00860014768606QuickBraceINNOMOTIVE L.L.CIQI2026-02-11
00690079011306Strassburg SockSTRASSBURG MEDICAL, LLCIQI2026-01-27
00690079011313Strassburg SockSTRASSBURG MEDICAL, LLCIQI2026-01-27
00690079012303Strassburg SockSTRASSBURG MEDICAL, LLCIQI2026-01-27
00690079012310Strassburg SockSTRASSBURG MEDICAL, LLCIQI2026-01-27
00810113682969ManaEZ Single Panel Knee Immobilizer 18"Manamed, Inc.IQI2025-11-25
00810113682976ManaEZ Single Panel Knee Immobilizer 20"Manamed, Inc.IQI2025-11-25
00810113682983ManaEZ Single Panel Knee Immobilizer 24"Manamed, Inc.IQI2025-11-25
00810113682990ManaEZ 3 Panel Knee Immobilizer 18"Manamed, Inc.IQI2025-11-25
00810113683003ManaEZ 3 Panel Knee Immobilizer 20"Manamed, Inc.IQI2025-11-25
00810113683010ManaEZ 3 Panel Knee Immobilizer 24"Manamed, Inc.IQI2025-11-25
00810113683294ManaEZ 3 Panel Knee Immobilizer 16"Manamed, Inc.IQI2025-11-25
00810079192144Thrive OrthopedicsThrive Orthopedics LLCIQI2025-11-24
00810079192151Thrive OrthopedicsThrive Orthopedics LLCIQI2025-11-24
00810079191918Thrive OrthopedicsThrive Orthopedics LLCIQI2025-11-17
00810079191925Thrive OrthopedicsThrive Orthopedics LLCIQI2025-11-17
00810079192311Thrive OrthopedicsThrive Orthopedics LLCIQI2025-11-17