DEVICE: iWALK3.0, the iWALKFree 3.0 Hands Free Crutch (00860002590813)

Device Identifier (DI) Information

iWALK3.0, the iWALKFree 3.0 Hands Free Crutch
HFC30303
In Commercial Distribution

IWALK FREE
00860002590813
GS1
January 01, 2031
1
079461204 *Terms of Use
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.
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Device Characteristics

MR Unsafe
No
No
Yes
No
Yes
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
17631 Single-side-support walking frame
A 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.
Active false
31114 Forearm support crutch
A staff-like mobility aid used to assist a person with a disability to support their weight while walking. The device has one or more legs and a padded support or "trough" in a horizontal position for the user to rest the forearm. The hand wraps around a grip at the end of the forearm support. The device may be adjustable in length and is typically made of metal [e.g., aluminium (Al), titanium (Ti)]. This device is particularly suited to individuals who cannot rest their weight on their hands.
Active false
31115 Axillary crutch
A staff-like mobility aid used to assist a person with a disability to support their weight while walking. The device has one leg, a padded hand support at the level of the user's wrist, and an under-arm (the armpit or axilla) padded platform. The pads are typically made of non-slip material (e.g., rubber, glycerin gel, sheepskin). The device may be adjustable in length and is typically made of wood or metal [e.g., aluminium (Al), titanium (Ti)].
Active false
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FDA Product Code

[?]
Product Code Product Code Name
IQI Orthosis, Limb Brace
IPR Crutch
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

3b3710c3-19b2-4fc8-9abd-8065c61ebb5f
March 16, 2021
1
March 08, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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