Duns Number:341439008
Device Description: powered muscle stimulator (8 channels) for use as stand-alone device as well as in combina
Catalog Number
FES00005
Brand Name
RehaStim 2 / RehaMove 2
Version/Model Number
FES00005
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 09, 2018
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K112844
Product Code
GZI
Product Code Name
Stimulator, Neuromuscular, External Functional
Public Device Record Key
26228a7e-8c84-4474-ac30-e7801c15278c
Public Version Date
February 19, 2021
Public Version Number
8
DI Record Publish Date
September 13, 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. | 6 |