Product Code: ILQ FDA class 2 21 CFR 890.3710

System, Communication, Powered

Physical Medicine

A Powered Communication System is an electronic augmentative and alternative communication device used in Physical Medicine to assist patients with speech or motor disabilities in producing and transmitting spoken or written communication, including speech-generating devices and computer-based communication aids. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device before marketing. The product code is ILQ, regulated under 21 CFR 890.3710, within the Physical Medicine medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: ILQ
Device Class: FDA class 2
Regulation Number: 890.3710
Medical Specialty: Physical Medicine
Review Panel: PM
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

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 38 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K162817	Noddle(TM)	Jan 18, 2017	Substantially Equivalent	Iowa Adaptive Technologies, Inc. Dba Voxello, Inc.
K943035	P.A.T. SYSTEM	Oct 04, 1994	Substantially Equivalent	Mathews Assoc., Inc.
K930044	COMFORT KEYBOARD SYSTEM	Jul 14, 1994	Substantially Equivalent	Health Care Keyboard Co., Inc.
K931855	LIGHTWRITER	May 10, 1994	Substantially Equivalent	Zygo Corp.
K935244	R & D BATTERIES, INC. PART NUMBER 5113	Apr 19, 1994	Substantially Equivalent	R & D Batteries, Inc.
K935981	MLT-2	Feb 17, 1994	Substantially Equivalent	Med Labs, Inc.
K925387	LIBERATOR	Mar 29, 1993	Substantially Equivalent	Prentke Romich Co.
K925527	LIGHT TALKER	Mar 22, 1993	Substantially Equivalent	Prentke Romich Co.
K924030	SCRIBE	Mar 04, 1993	Substantially Equivalent	Zygo Industries, Inc.
K924015	PARROT	Mar 04, 1993	Substantially Equivalent	Zygo Industries, Inc.
K924014	SECRETARY	Mar 04, 1993	Substantially Equivalent	Zygo Industries, Inc.
K924013	MACAW	Mar 04, 1993	Substantially Equivalent	Zygo Industries, Inc.
K923819	EEC-1 PACKAGE	Nov 06, 1992	Substantially Equivalent	Med Labs, Inc.
K914259	TOUCH TALKER	Feb 27, 1992	Substantially Equivalent	Prentke Romich Co.
K914103	LIFELINE(R) PERSONAL RESPONSE SYSTEM	Sep 27, 1991	Substantially Equivalent	Lifeline Systems, Inc.
K910819	COMPANION SPEECH AID, MODEL 160	Mar 07, 1991	Substantially Equivalent	Companion Products Intl.
K910796	COMPANION SPEECH AID, MODEL 432	Mar 07, 1991	Substantially Equivalent	Companion Products Intl.
K905474	THE EYEGAZE SYSTEM	Feb 28, 1991	Substantially Equivalent	Lc Technologies, Inc.
K905576	LINGRAPHICA VISUAL LANGUAGE PROSTHESIS	Dec 31, 1990	Substantially Equivalent	Tolfa Corp.
K904796	MEDICAL ALERT SYSTEM, MODEL 2200 & 4400 V/T	Nov 26, 1990	Substantially Equivalent	Personal Emergency Response System
K903605	CINTEX	Sep 14, 1990	Substantially Equivalent	Nanopac, Inc.
K903652	SCAN COM AND SCAN COM P (TENTATIVE)	Aug 24, 1990	Substantially Equivalent	Med Labs, Inc.
K902206	CONTROL 1 ENVIRONMENTAL CONTROL	May 29, 1990	Substantially Equivalent	Prentke Romich Co.
K901030	ROTARY COMMUNICATION SCANNER MODEL 7010	Mar 13, 1990	Substantially Equivalent	Baylor Biomedical Services
K901029	YES-NO VOICE BOX 7011	Mar 13, 1990	Substantially Equivalent	Baylor Biomedical Services
K893473	COMMUNI-CALL	Jun 09, 1989	Substantially Equivalent	Carepartners, Inc.
K864204	VOCAID, ELECTRONIC VOCAL AID	Nov 14, 1986	Substantially Equivalent	Texas Instruments, Inc.
K863995	KEYNOTE	Nov 13, 1986	Substantially Equivalent	Sensory Aids Corp.
K842535	PENTAD VOCALIZER	Jul 13, 1984	Substantially Equivalent	Pentad Corp.
K841528	CONVAID - SPEECH AID	May 09, 1984	Substantially Equivalent	Convaid , Ltd.
K831093	APELLO, PERSONAL HEALTH SUPPORT SYS.	May 16, 1983	Substantially Equivalent	Almicro Electronics, Inc.
K821677	THE COMMUNICATOR	Jun 22, 1982	Substantially Equivalent	Robert Swinney. , Ltd.
K812720	BODAI PATIENT COMMUNICATOR	Nov 05, 1981	Substantially Equivalent	Sontek Industries, Inc.
K802687	SPEAKEASY COMMUN. SYSTEM-COMM. PROTHESIS	Feb 04, 1981	Substantially Equivalent	Intelligent Software Systems, Inc.
K771825	CARBA LINGUARDUC	Oct 06, 1977	Substantially Equivalent	C.R. Bard, Inc.
K770031	ALARM INTERCOM DOOR LOCK	Jan 12, 1977	Substantially Equivalent	Possum, Inc.
K770030	ALARM, COMMUN.-SEC. INDEP.-EMER.	Jan 12, 1977	Substantially Equivalent	Possum, Inc.
K770029	TYPEWRITER CONTROL SYSTEMS	Jan 12, 1977	Substantially Equivalent	Possum, Inc.