Duns Number:530683813
Device Description: Decompression BeltThis product is used for external fixation of the waist and longitudinal Decompression BeltThis product is used for external fixation of the waist and longitudinal traction of the lumbar spine.It is composed by traction belt and air pump
Catalog Number
-
Brand Name
DR-HO'S
Version/Model Number
Size A/B
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HST
Product Code Name
Apparatus, Traction, Non-Powered
Public Device Record Key
c13a0cee-7b18-435e-81cb-2f46b564e6a4
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 |