Duns Number:021461470
Device Description: A rehabilitation device for upper extremity strength testing and exercise. The dynamometer A rehabilitation device for upper extremity strength testing and exercise. The dynamometer offers isometric and concentric isotonic modes, as well as many adapters for isolated joint and compound motions.
Catalog Number
-
Brand Name
Simulator II
Version/Model Number
Sim II 5
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
K800007
Product Code
BXB
Product Code Name
Exerciser, Powered
Public Device Record Key
4116c815-d37e-49ff-bf95-4970b1503387
Public Version Date
May 08, 2020
Public Version Number
6
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 |