Duns Number:079461204
Device Description: iWALK3.0 is a assistive mobility device most accurately described as a hands free crutch. 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.
Catalog Number
-
Brand Name
iWALK3.0, the iWALKFree 3.0 Hands Free Crutch
Version/Model Number
HFC30303
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 01, 2031
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IPR
Product Code Name
Crutch
Public Device Record Key
3b3710c3-19b2-4fc8-9abd-8065c61ebb5f
Public Version Date
March 16, 2021
Public Version Number
1
DI Record Publish Date
March 08, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |