Duns Number:544436531
Device Description: It is a product not also can be used as medical purposes specified in Intended use, but al It is a product not also can be used as medical purposes specified in Intended use, but also It can help to-Correct your standing,sitting and walking posture- Prevent deformation of spinal column- Ease human body fatigued- Contribute to growing development-Make your waist and back stay straight and reducing lower back pain,slouching and hunching.It is good for adjusting and make human spine keep straight. The soft and thin cloth will be close to human body, which will not influence the good appearance after you wear it.
Catalog Number
-
Brand Name
Konmed
Version/Model Number
KM-C-12
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
IQE
Product Code Name
Orthosis, Lumbar
Public Device Record Key
fd8506f3-7308-454d-b52d-348d517ae22f
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 |