IQA · System, Environmental Control, Powered
Physical Medicine · 21 CFR 890.3725 · Class 2
Overview
| Product Code | IQA |
|---|---|
| Device Name | System, Environmental Control, Powered |
| Regulation | 21 CFR 890.3725 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
Identification
A powered environmental control system is an AC- or battery-powered device intended for medical purposes that is used by a patient to operate an environmental control function. Examples of environmental control functions include the following: to control room temperature, to answer a doorbell or telephone, or to sound an alarm for assistance.
Classification Rationale
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.
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.
Recent Cleared Devices (20 of 24)
Showing 20 most recent of 24 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K961306 | DELTATALKER WITH INFRARED | Prentke Romich Co. | Jun 27, 1996 | SESE |
| K953905 | IMPERIUM | Teledyne Brown Engineering | Nov 21, 1995 | SESE |
| K953937 | LIAISON COMPUTER ACCESS & ENVIRONMENTAL CONTROL SYSTEM | Apt Technology, Inc. | Oct 31, 1995 | SESE |
| K943244 | DEUCE | Apt Technology, Inc. | Sep 11, 1995 | SESE |
| K944585 | SCANNING DIRECTOR | Prentke Romich Co. | Feb 21, 1995 | SESE |
| K944345 | BEDSIDE BUTLER | Trac Medical, Inc. | Oct 17, 1994 | SESE |
| K940223 | LEARN MODE WATERPROOF PENDANT PANIC BUTTON | Interactive Technologies, Inc. | Apr 29, 1994 | SESE |
| K926029 | INFRA-LINK | Zygo Industries, Inc. | Mar 26, 1993 | SESE |
| K921528 | HILL-ROM PATIENT ENVIRONMENTAL CONTROL SYSTEM | Hill-Rom, Inc. | Apr 20, 1992 | SESE |
| K911101 | TONGUETOUCH KEYPAD AND ZOFCOM CONTROL SYSTEM | Zofcom, Inc. | Apr 25, 1991 | SESE |
| K902664 | HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1 | Prentke Romich Co. | Jul 25, 1990 | SESE |
| K901028 | ENVIRONMENTAL CONTROL UNIT MODEL 7000 | Baylor Biomedical Services | Mar 13, 1990 | SESE |
| K900969 | REMOTE CONTROL SWITCH | Baylor Biomedical Services | Mar 13, 1990 | SESE |
| K890596 | MED-A-CALL ASSIST DEVICE | Silent Call Corp. | Mar 14, 1989 | SESE |
| K881634 | SIMPLICITY SERIES 5 | Quartet Technology, Inc. | May 17, 1988 | SESE |
| K873612 | IMSI, VITAL CALL | Intl. Management Services, Inc. | Nov 23, 1987 | SESE |
| K872937 | 97-TD EMERSON TIMER/DIMMER CONTROL | J. H. Emerson Co. | Sep 24, 1987 | SESE |
| K872936 | 97-D EMERSON DIMMER CONTROL | J. H. Emerson Co. | Sep 24, 1987 | SESE |
| K851740 | EZZIE SYSTEM | Independent Living, Inc. | Jul 15, 1985 | SESE |
| K850314 | TELEVISION CONTROL OPTION 1220 | Rehab Technology, Inc. | Apr 25, 1985 | SESE |
Top Applicants
- Prentke Romich Co. — 3 clearances
- Rehab Technology, Inc. — 3 clearances
- Apt Technology, Inc. — 2 clearances
- Baylor Biomedical Services — 2 clearances
- J. H. Emerson Co. — 2 clearances
