Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart D — Physical Medicine Prosthetic Devices](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices) → [21 CFR 890.3725](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/890.3725) → IQA — System, Environmental Control, Powered # IQA · System, Environmental Control, Powered _Physical Medicine · 21 CFR 890.3725 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQA ## Overview - **Product Code:** IQA - **Device Name:** System, Environmental Control, Powered - **Regulation:** [21 CFR 890.3725](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/890.3725) - **Device Class:** 2 - **Review Panel:** [Physical Medicine](/submissions/PM) ## 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](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQA/K961306.md) | DELTATALKER WITH INFRARED | Prentke Romich Co. | Jun 27, 1996 | SESE | | [K953905](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQA/K953905.md) | IMPERIUM | Teledyne Brown Engineering | Nov 21, 1995 | SESE | | [K953937](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQA/K953937.md) | LIAISON COMPUTER ACCESS & ENVIRONMENTAL CONTROL SYSTEM | Apt Technology, Inc. | Oct 31, 1995 | SESE | | [K943244](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQA/K943244.md) | DEUCE | Apt Technology, Inc. | Sep 11, 1995 | SESE | | [K944585](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQA/K944585.md) | SCANNING DIRECTOR | Prentke Romich Co. | Feb 21, 1995 | SESE | | [K944345](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQA/K944345.md) | BEDSIDE BUTLER | Trac Medical, Inc. | Oct 17, 1994 | SESE | | [K940223](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQA/K940223.md) | LEARN MODE WATERPROOF PENDANT PANIC BUTTON | Interactive Technologies, Inc. | Apr 29, 1994 | SESE | | [K926029](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQA/K926029.md) | INFRA-LINK | Zygo Industries, Inc. | Mar 26, 1993 | SESE | | [K921528](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQA/K921528.md) | HILL-ROM PATIENT ENVIRONMENTAL CONTROL SYSTEM | Hill-Rom, Inc. | Apr 20, 1992 | SESE | | [K911101](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQA/K911101.md) | TONGUETOUCH KEYPAD AND ZOFCOM CONTROL SYSTEM | Zofcom, Inc. | Apr 25, 1991 | SESE | | [K902664](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQA/K902664.md) | HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1 | Prentke Romich Co. | Jul 25, 1990 | SESE | | [K901028](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQA/K901028.md) | ENVIRONMENTAL CONTROL UNIT MODEL 7000 | Baylor Biomedical Services | Mar 13, 1990 | SESE | | [K900969](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQA/K900969.md) | REMOTE CONTROL SWITCH | Baylor Biomedical Services | Mar 13, 1990 | SESE | | [K890596](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQA/K890596.md) | MED-A-CALL ASSIST DEVICE | Silent Call Corp. | Mar 14, 1989 | SESE | | [K881634](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQA/K881634.md) | SIMPLICITY SERIES 5 | Quartet Technology, Inc. | May 17, 1988 | SESE | | [K873612](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQA/K873612.md) | IMSI, VITAL CALL | Intl. Management Services, Inc. | Nov 23, 1987 | SESE | | [K872937](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQA/K872937.md) | 97-TD EMERSON TIMER/DIMMER CONTROL | J. H. Emerson Co. | Sep 24, 1987 | SESE | | [K872936](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQA/K872936.md) | 97-D EMERSON DIMMER CONTROL | J. H. Emerson Co. | Sep 24, 1987 | SESE | | [K851740](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQA/K851740.md) | EZZIE SYSTEM | Independent Living, Inc. | Jul 15, 1985 | SESE | | [K850314](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQA/K850314.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQA](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQA) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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