Duns Number:519969810
Device Description: Highly sensitive Myo-EX sensors use surface EMG for inspiring exercise, beginning from whe Highly sensitive Myo-EX sensors use surface EMG for inspiring exercise, beginning from when there is the tiniest flicker of voluntary muscle activity, with or without visible joint movement.GX1 sensor with integral electrodes is applied to the skin with die-cut medical grade hypoallergenic tape.This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13
Catalog Number
-
Brand Name
E-LINK Myo-EX GX1 EMG Sensor
Version/Model Number
GX1
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)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HCC
Product Code Name
Device, Biofeedback
Public Device Record Key
a37bcbdb-9360-4de6-931b-ddc94194a4b7
Public Version Date
September 10, 2018
Public Version Number
1
DI Record Publish Date
August 10, 2018
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 | 27 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |