MOUTH STICK KIT
Device Facts
| Record ID | K823625 |
|---|---|
| Device Name | MOUTH STICK KIT |
| Applicant | Fred Sammons, Inc. |
| Product Code | ILP · Physical Medicine |
| Decision Date | Dec 30, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3700 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A nonpowered communication system is a mechanical device intended for medical purposes that is used to assist a patient in communicating when physical impairment prevents writing, telephone use, reading, or talking. Examples of nonpowered communications systems include an alphabet board and a page turner.
