Duns Number:519969810
Device Description: The EX2 Interface Unit is used to connect the M400 Myo-EX (GX1, GX2) and AngleX (NC1, NC2) The EX2 Interface Unit is used to connect the M400 Myo-EX (GX1, GX2) and AngleX (NC1, NC2) sensors to E3000 Serial Interface Upper Limb Exerciser.This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13
Catalog Number
-
Brand Name
E-LINK EX2 Interface Unit for M400
Version/Model Number
EX2
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)
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Over the Counter (OTC)
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Kit
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Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
-
Product Code
BXB
Product Code Name
Exerciser, Powered
Public Device Record Key
76ec4b9e-321b-4ca0-9c49-e73f7bd157f0
Public Version Date
November 10, 2021
Public Version Number
2
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 |