Duns Number:113424464
Device Description: Hand dynamometer intended for use with the AcroVal™ Neurosensory & Motor Testing System (N Hand dynamometer intended for use with the AcroVal™ Neurosensory & Motor Testing System (NSMTS) to measure the pinch force of a patient’s fingers.
Catalog Number
-
Brand Name
AcroPinch™ Device
Version/Model Number
EN-248
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"
-
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
K914056
Product Code
LBB
Product Code Name
Dynamometer, Ac-Powered
Public Device Record Key
75d227c8-15e1-493a-a73b-c060a2abff43
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
May 15, 2017
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |