Freedom Switch

FDA UDI

Class II (US FDA UDI)

by Prentke Romich Company

Identity

Trade Name: Freedom Switch FDA UDI
Generic Name: Voice synthesizer/digitizer FDA UDI
Device Name: 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. FDA UDI
Model / Reference: FS-2 FDA UDI
Description: 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. FDA UDI

Identifiers

Primary DI / UDI-DI: 00858526006637 FDA UDI
FDA Product Code: ILQ FDA UDI
GMDN Term: Voice synthesizer/digitizer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.3710 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 2.875 Inch FDA UDI
Height — 0.625 Inch FDA UDI

Category: Voice synthesizer/digitizer

Freedom Switch by Prentke Romich Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Prentke Romich Company

Sources (1)

FDA UDI f7bcb4e7-b8cc-4b52-87eb-11324f9f8163 35 fields · synced May 30, 2026