Duns Number:428484518
Device Description: BTS FREEEMG 1000 is a wireless surface electromyograph for the acquisition and transmissio BTS FREEEMG 1000 is a wireless surface electromyograph for the acquisition and transmission of EMG signals and for the assessment of angles, angular velocities, angular accelerations and foot-floor contact areas.It allows the functional evaluation and a real-time visualization of the acquired signals for biofeedback and monitoring applications.
Catalog Number
BTSEMB1BM
Brand Name
FREEEMG
Version/Model Number
1000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HCC
Product Code Name
Device, Biofeedback
Public Device Record Key
21b2ae05-50aa-4c53-935f-e9d57348a8df
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 06, 2016
Package DI Number
B179FR11
Quantity per Package
1
Contains DI Package
B179FR1
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
customized bag
| 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. | 7 |