Duns Number:544436531
Device Description: It is a product can be used as medical purposes specified in Intended use and it is easy t It is a product can be used as medical purposes specified in Intended use and it is easy to wear and take off and with humanized design, which can be adjustable by customer desired with below feature:- The half-hard design at the bottom of the device and adjust and swing according to human walking habit, while the thin and soft design make it easy to wear and can help to recovery and satisfy patient’sdemand- The hollow designing on the heel part is good to wear- The cushion on the shin and shank can be disassembled, which is convenient to wash and good to maintain hygienic- With left and right design difference- The tiptoe part can be trimmed based on your size- The “8” shape straps is detachable
Catalog Number
-
Brand Name
Konmed
Version/Model Number
KM-F-58
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
-
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
ITW
Product Code Name
Joint, Ankle, External Brace
Public Device Record Key
68ff0c70-6ada-4a4c-829b-68011e5646e8
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
January 24, 2018
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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |