FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Freedom Switch
DI: 00858526006552
·
Model: FS
·
PRENTKE ROMICH COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Freedom Switch
- Primary DI
- 00858526006552
- Version / Model
- FS
- Company Name
- PRENTKE ROMICH COMPANY
- Labeler DUNS
- 080143399
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2019-07-25
- Public Version Status
- Update
- Public Device Record Key
- 439ed84d-972c-4c53-b380-31bff443054e
- Distribution End Date
- 2017-04-28
Device 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, but requires the use of the stereo cable which is included with the Freedom Switch Kit. 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ILQ | System, Communication, Powered | Physical Medicine | 890.3710 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17187 | Voice synthesizer/digitizer | An assistive device designed to deliver voice output based either in the reproduction of previously-recorded natural speech and/or on an electronic synthesized voice following a pre-established set of pronunciation rules. It typically consists of an electronic unit with a keyboard and screen; the keyboard may include letters, symbols, or both. The device is often customized to meet the user?s needs and is mostly used by patients with disabilities that partially or totally impair voice capabilities, including chronic progressive diseases. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858526006552 | GS1 |
Customer Contacts
- Phone
- 800-262-1984
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 0.625 | Inch | |
| Outer Diameter | 2.875 | Inch |