BIGmack
Basic Information
- Primary DI
- 00850011150061
- Basic UDI-DI Code
- 085001115010000041E8
- Reference
- 10000041
- Device Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 1
- Status
- On The Market
- Manufacturer
- AbleNet Inc.
Additional Description
About Start your communication journey with a BIGmack speech device. With a press of the large colored top, an individual can communicate a single message up to 2-minutes long. New messages are easily and quickly recorded to the BIGmack on the fly throughout the day to provide opportunities to communicate in almost any scenario. Includes ableCARE on-demand support Built ableSTRONG to endure drops and other environmental conditions Made from ableSAFE materials and tested by third-party safety labs Common Uses Request like "I want" or "I need help" Participate in an activity with "turn the page" or "It's your turn" Tell your classmates what you did over the weekend during a morning meeting Add communication to a switch controlled toy or applianceg Features Better than ever digital sound output suitable for almost any environment Includes red, yellow, green, and blue colored tops Clear snap cover to attach picture symbols and provide communication context to the user Soft-touch coating makes the device easier to hold
CND Nomenclature Codes
| Code | Description |
|---|---|
| Y214212 | VOICE GENERATORS |
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDR).