Duns Number:519969810
Device Description: A modern microprocessor controlled general purpose amplifier system which is designed to b A modern microprocessor controlled general purpose amplifier system which is designed to be worn by the subject. The Amplifier (K800) provides a user friendly method for collecting signals from a variety of sensors including goniometers, sEMG and related signals, in a format which may readily be connected to proprietary display and recording systems including A/D cards.This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13
Catalog Number
-
Brand Name
K800 Amplifier
Version/Model Number
K800
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
8f6e0e08-2715-4806-806e-67e09a356b1f
Public Version Date
September 10, 2018
Public Version Number
1
DI Record Publish Date
August 10, 2018
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 | 27 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |