Duns Number:080143399
Device Description: The Freedom Switch is a wireless switch that uses radio frequency to communicate with the The Freedom Switch is a wireless switch that uses radio frequency to communicate with the host device and provides a reliable connection for switch activation. Two Freedom Switches can be used together for dual switch applications. The Freedom Switch works with the Accent 1400, Accent 1000, Accent 800, and Accent 700.Wired switches can also be connected to the Freedom Switch for single or two switch applications.Freedom Switch dimensions: Height 5/8" (.625); Diameter 2 7/8" (2.875)The Freedom Switch is available in Red, Green, Blue or Yellow. Colors are subject to availability.
Catalog Number
-
Brand Name
Freedom Switch
Version/Model Number
FS-2
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)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ILQ
Product Code Name
System, Communication, Powered
Public Device Record Key
f7bcb4e7-b8cc-4b52-87eb-11324f9f8163
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 03, 2017
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 198 |