Duns Number:519969810
Device Description: The MyoMeter allows the user to quantify the force applied during Manual Muscle Testing.Th The MyoMeter allows the user to quantify the force applied during Manual Muscle Testing.This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013
Catalog Number
-
Brand Name
Biometrics Ltd M550 MyoMeter
Version/Model Number
M550
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)
-
Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IKK
Product Code Name
System, Isokinetic Testing And Evaluation
Public Device Record Key
d3b8e62c-bd22-4ee8-b2f3-f24711cd0288
Public Version Date
August 10, 2018
Public Version Number
3
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 |