MEDICAL ALERT SYSTEM, MODEL 2200 & 4400 V/T
Device Facts
| Record ID | K904796 |
|---|---|
| Device Name | MEDICAL ALERT SYSTEM, MODEL 2200 & 4400 V/T |
| Applicant | Personal Emergency Response System |
| Product Code | ILQ · Physical Medicine |
| Decision Date | Nov 26, 1990 |
| 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.
