Duns Number:524664525
Device Description: Grip is used for the evaluation of hand grip strength. You can assess isometric strength b Grip is used for the evaluation of hand grip strength. You can assess isometric strength by the way of the peak force as well as of the average force. The Grip dynamometer allows to quantitatively measure the grip weakness caused by injury compared to the strength of the healthy hand
Catalog Number
-
Brand Name
KINVENT
Version/Model Number
Grip V2R01
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
LBB
Product Code Name
Dynamometer, Ac-Powered
Public Device Record Key
15093b4a-56d4-4321-bfc1-8956f4e39cbc
Public Version Date
November 30, 2021
Public Version Number
2
DI Record Publish Date
August 01, 2020
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |