COMPANION SPEECH AID, MODEL 432
Device Facts
| Record ID | K910796 |
|---|---|
| Device Name | COMPANION SPEECH AID, MODEL 432 |
| Applicant | Companion Products Intl. |
| Product Code | ILQ · Physical Medicine |
| Decision Date | Mar 7, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3710 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A powered communication system is an AC- or battery-powered device intended for medical purposes that is used to transmit or receive information. It is used by persons unable to use normal communication methods because of physical impairment. Examples of powered communication systems include the following: a specialized typewriter, a reading machine, and a video picture and word screen.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
