Duns Number:519969810
Device Description: Accurate measurements of upper and lower extremity ROM with precise electronic tools for e Accurate measurements of upper and lower extremity ROM with precise electronic tools for evaluation and progress reporting:Wrist, Forearm, Elbow, Shoulder, Hip, Knee, Ankle, Documentation of amputation, ankylosis, and arthrodesis for the above jointsThis product is independently tested and certified to BS EN 60601-1:2006 + A1:2013
Catalog Number
-
Brand Name
E-LINK N400 Large Goniometer
Version/Model Number
N400
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"
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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
ISD
Product Code Name
Exerciser, Measuring
Public Device Record Key
55bc5efe-9c76-42a7-819d-dac62432655e
Public Version Date
August 10, 2018
Public Version Number
2
DI Record Publish Date
May 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 |