Duns Number:530683813
Device Description: Large Replacement Electrodes (Flex Tone Pads): An electrode pad that conducts electrical s Large Replacement Electrodes (Flex Tone Pads): An electrode pad that conducts electrical signals to the skin
Catalog Number
-
Brand Name
DR -HOS
Version/Model Number
RP-II
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K172887
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
b55aec83-b4ae-4aa5-87bc-244f834948c1
Public Version Date
August 24, 2021
Public Version Number
1
DI Record Publish Date
August 16, 2021
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 |