Duns Number:021461470
Device Description: A recumbent, closed-chain exercise device that provides eccentric (negative) resistance to A recumbent, closed-chain exercise device that provides eccentric (negative) resistance to lower extremity motion. It also measures strength and dynamic workload through its computer interface.
Catalog Number
-
Brand Name
Eccentron
Version/Model Number
LE1
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
-
Product Code
IKK
Product Code Name
System, Isokinetic Testing And Evaluation
Public Device Record Key
b5370b0d-e85b-46bd-a231-792c268ba352
Public Version Date
May 13, 2020
Public Version Number
4
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 |