Duns Number:530683813
Device Description: Neck ComforterThis product is used for the peripheral fixation of the neck and the longitu Neck ComforterThis product is used for the peripheral fixation of the neck and the longitudinal traction of the cervical vertebra.It is composed by cloth sleeves, three TPU round air bags and inflatable balls.It is mainly through stretching the cervical interspace under the inflatable state, reducing the pressure of the cervical interspace, improving the burden of the ligaments around the cervical vertebra, so that the injured cervical vertebra can get a full rest.
Catalog Number
-
Brand Name
DR-HO'S
Version/Model Number
XB-JT1000
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KQZ
Product Code Name
Component, Traction, Non-Invasive
Public Device Record Key
021a3228-5854-4a26-bdf2-4e99323fa820
Public Version Date
August 20, 2020
Public Version Number
2
DI Record Publish Date
March 01, 2020
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 | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 26 |