Duns Number:053824652
Device Description: Utilizing high quality bipolar surface electrodes, surface EMG data can be taken from up t Utilizing high quality bipolar surface electrodes, surface EMG data can be taken from up to eight muscle sites simultaneously and in real time. The program permits taking electromyography data either at rest or in function. All eight channels may be displayed simultaneously, for a period of 15 seconds (one visual screen width). The K7/EMG signal processing circuitry provides unsurpassed protection against system noise or motion artifact. The patient education mode permits quick and easy patient education as to status of masticatory muscles.
Catalog Number
-
Brand Name
K7 Evaluation System-EMG
Version/Model Number
K7/EMG
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
IKN
Product Code Name
Electromyograph, Diagnostic
Public Device Record Key
90a1c950-ed6e-4668-be9b-f32fdd6ed215
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 19, 2016
Package DI Number
D07920978
Quantity per Package
1
Contains DI Package
D79209930
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |