Duns Number:013052325
Device Description: Self-adhering reusable stimulating electrodes that are intended to be used to apply electr Self-adhering reusable stimulating electrodes that are intended to be used to apply electrical stimulation current to the patient's skin. An example electrical stimulation current application of these electrodes is neuro-muscular electrical stimulation including for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction. Each package contains 4 electrodes with a size of 1.5 in. x 1.75 in. and are single patient use only.
Catalog Number
50709LT
Brand Name
E Series
Version/Model Number
50709LT
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
K121483,K121483
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
61f6969d-56ad-475f-bb2e-9d16a2c16a68
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
March 15, 2017
Package DI Number
10867786000207
Quantity per Package
10
Contains DI Package
00867786000200
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pouch
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |