Duns Number:021461470
Device Description: A very versatile rehabilitation device for upper extremity and lower extremity strength te A very versatile rehabilitation device for upper extremity and lower extremity strength testing and exercise. The dynamometer offers isometric, isotonic, isokinetic, eccentric, concentric, and continuous passive motion modes, as well as many adapters for isolated joint and compound motions.
Catalog Number
-
Brand Name
Primus
Version/Model Number
Primus+
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 16, 2022
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
K933611
Product Code
ISD
Product Code Name
Exerciser, Measuring
Public Device Record Key
165f40bb-b283-4b26-b0a2-7c77d546eb5c
Public Version Date
June 17, 2022
Public Version Number
7
DI Record Publish Date
August 25, 2016
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |