Product Code: IQA FDA class 2 21 CFR 890.3725

System, Environmental Control, Powered

Physical Medicine

A powered environmental control system is an electronic device that allows individuals with physical disabilities to control household appliances, communication devices, and other environmental elements through alternative input methods. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket notification before marketing. The product code is IQA, regulated under 21 CFR 890.3725, within the Physical Medicine medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: IQA
Device Class: FDA class 2
Regulation Number: 890.3725
Medical Specialty: Physical Medicine
Review Panel: PM
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 24 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K961306	DELTATALKER WITH INFRARED	Jun 27, 1996	Substantially Equivalent	Prentke Romich Co.
K953905	IMPERIUM	Nov 21, 1995	Substantially Equivalent	Teledyne Brown Engineering
K953937	LIAISON COMPUTER ACCESS & ENVIRONMENTAL CONTROL SYSTEM	Oct 31, 1995	Substantially Equivalent	Apt Technology, Inc.
K943244	DEUCE	Sep 11, 1995	Substantially Equivalent	Apt Technology, Inc.
K944585	SCANNING DIRECTOR	Feb 21, 1995	Substantially Equivalent	Prentke Romich Co.
K944345	BEDSIDE BUTLER	Oct 17, 1994	Substantially Equivalent	Trac Medical, Inc.
K940223	LEARN MODE WATERPROOF PENDANT PANIC BUTTON	Apr 29, 1994	Substantially Equivalent	Interactive Technologies, Inc.
K926029	INFRA-LINK	Mar 26, 1993	Substantially Equivalent	Zygo Industries, Inc.
K921528	HILL-ROM PATIENT ENVIRONMENTAL CONTROL SYSTEM	Apr 20, 1992	Substantially Equivalent	Hill-Rom, Inc.
K911101	TONGUETOUCH KEYPAD AND ZOFCOM CONTROL SYSTEM	Apr 25, 1991	Substantially Equivalent	Zofcom, Inc.
K902664	HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1	Jul 25, 1990	Substantially Equivalent	Prentke Romich Co.
K901028	ENVIRONMENTAL CONTROL UNIT MODEL 7000	Mar 13, 1990	Substantially Equivalent	Baylor Biomedical Services
K900969	REMOTE CONTROL SWITCH	Mar 13, 1990	Substantially Equivalent	Baylor Biomedical Services
K890596	MED-A-CALL ASSIST DEVICE	Mar 14, 1989	Substantially Equivalent	Silent Call Corp.
K881634	SIMPLICITY SERIES 5	May 17, 1988	Substantially Equivalent	Quartet Technology, Inc.
K873612	IMSI, VITAL CALL	Nov 23, 1987	Substantially Equivalent	Intl. Management Services, Inc.
K872937	97-TD EMERSON TIMER/DIMMER CONTROL	Sep 24, 1987	Substantially Equivalent	J. H. Emerson Co.
K872936	97-D EMERSON DIMMER CONTROL	Sep 24, 1987	Substantially Equivalent	J. H. Emerson Co.
K851740	EZZIE SYSTEM	Jul 15, 1985	Substantially Equivalent	Independent Living, Inc.
K850314	TELEVISION CONTROL OPTION 1220	Apr 25, 1985	Substantially Equivalent	Rehab Technology, Inc.
K850313	TELEVISION CONTROL OPTION 1219	Apr 25, 1985	Substantially Equivalent	Rehab Technology, Inc.
K840808	ECU 1218	Mar 19, 1984	Substantially Equivalent	Rehab Technology, Inc.
K832057	NURSE CALL BUTTON	Jul 12, 1983	Substantially Equivalent	Qa Alert Systems
K770028	ENVIRONMENTAL CONTROL SYSTEMS	Jan 12, 1977	Substantially Equivalent	Possum, Inc.