Duns Number:519969810
Device Description: The Biometrics Dynamometer utilises precision load cell technology to increase the sensiti The Biometrics Dynamometer utilises precision load cell technology to increase the sensitivity and accuracy of measurement of even very low grip strength forces. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13
Catalog Number
-
Brand Name
Biometrics Ltd Dynamometer
Version/Model Number
G100
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
-
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
HCC
Product Code Name
Device, Biofeedback
Public Device Record Key
9d577c90-3649-4303-ba87-760e28e04665
Public Version Date
September 10, 2018
Public Version Number
1
DI Record Publish Date
August 09, 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 |