NON-POWERED COMMUNICATION SYSTEMS
Device Facts
| Record ID | K810452 |
|---|---|
| Device Name | NON-POWERED COMMUNICATION SYSTEMS |
| Applicant | Fred Sammons, Inc. |
| Product Code | ILP · Physical Medicine |
| Decision Date | Mar 4, 1981 |
| 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.
