Duns Number:625133228
Device Description: RS-LB Conductive Low Back Garment System, Snap adapter and treatment electrodes
Catalog Number
-
Brand Name
RS-CLBG Conductive Low Back Garment
Version/Model Number
959-0053-00
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K090951
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
a6477768-265b-4281-9d34-736fda3a66e5
Public Version Date
September 22, 2022
Public Version Number
1
DI Record Publish Date
September 14, 2022
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 15 |