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System, Communication, Powered

Regulation 890.3710

0510(k)s in 12 months (38 all time)
2recalls in 12 months (19 all time)
4recalls that name a 510(k)
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Top companies in ILQ

Company510(k)sRecalls
Lifeline Systems, Inc.13
Prentke Romich Co.40
Zygo Industries, Inc.40
Baxter Healthcare Corporation03
Med Labs, Inc.30
Possum, Inc.30
Tobii Dynavox Llc03
Baylor Biomedical Services20
Companion Products Intl.20
Dynavox Systems Llc02
Decided510(k)Device and applicantCode
Jan 18, 2017K162817Noddle(TM)
Iowa Adaptive Technologies, Inc. Dba Voxello, Inc.
ILQ
Oct 4, 1994K943035P.A.T. SYSTEM
Mathews Assoc., Inc.
ILQ
Jul 14, 1994K930044COMFORT KEYBOARD SYSTEM
Health Care Keyboard Co., Inc.
ILQ
May 10, 1994K931855LIGHTWRITER
Zygo Corp.
ILQ
Apr 19, 1994K935244R & D BATTERIES, INC. PART NUMBER 5113
R & D Batteries, Inc.
ILQ
Feb 17, 1994K935981MLT-2
Med Labs, Inc.
ILQ
Mar 29, 1993K925387LIBERATOR
Prentke Romich Co.
ILQ
Mar 22, 1993K925527LIGHT TALKER
Prentke Romich Co.
ILQ
Mar 4, 1993K924030SCRIBE
Zygo Industries, Inc.
ILQ
Mar 4, 1993K924015PARROT
Zygo Industries, Inc.
ILQ
Mar 4, 1993K924014SECRETARY
Zygo Industries, Inc.
ILQ
Mar 4, 1993K924013MACAW
Zygo Industries, Inc.
ILQ
Nov 6, 1992K923819EEC-1 PACKAGE
Med Labs, Inc.
ILQ
Feb 27, 1992K914259TOUCH TALKER
Prentke Romich Co.
ILQ
Sep 27, 1991K914103LIFELINE(R) PERSONAL RESPONSE SYSTEM
Lifeline Systems, Inc.
ILQ
Mar 7, 1991K910819COMPANION SPEECH AID, MODEL 160
Companion Products Intl.
ILQ
Mar 7, 1991K910796COMPANION SPEECH AID, MODEL 432
Companion Products Intl.
ILQ
Feb 28, 1991K905474THE EYEGAZE SYSTEM
Lc Technologies, Inc.
ILQ
Dec 31, 1990K905576LINGRAPHICA VISUAL LANGUAGE PROSTHESIS
Tolfa Corp.
ILQ
Nov 26, 1990K904796MEDICAL ALERT SYSTEM, MODEL 2200 & 4400 V/T
Personal Emergency Response System
ILQ
Sep 14, 1990K903605CINTEX
Nanopac, Inc.
ILQ
Aug 24, 1990K903652SCAN COM AND SCAN COM P (TENTATIVE)
Med Labs, Inc.
ILQ
May 29, 1990K902206CONTROL 1 ENVIRONMENTAL CONTROL
Prentke Romich Co.
ILQ
Mar 13, 1990K901030ROTARY COMMUNICATION SCANNER MODEL 7010
Baylor Biomedical Services
ILQ
Mar 13, 1990K901029YES-NO VOICE BOX 7011
Baylor Biomedical Services
ILQ
Jun 9, 1989K893473COMMUNI-CALL
Carepartners, Inc.
ILQ
Nov 14, 1986K864204VOCAID, ELECTRONIC VOCAL AID
Texas Instruments, Inc.
ILQ
Nov 13, 1986K863995KEYNOTE
Sensory Aids Corp.
ILQ
Jul 13, 1984K842535PENTAD VOCALIZER
Pentad Corp.
ILQ
May 9, 1984K841528CONVAID - SPEECH AID
Convaid , Ltd.
ILQ
May 16, 1983K831093APELLO, PERSONAL HEALTH SUPPORT SYS.
Almicro Electronics, Inc.
ILQ
Jun 22, 1982K821677THE COMMUNICATOR
Robert Swinney. , Ltd.
ILQ
Nov 5, 1981K812720BODAI PATIENT COMMUNICATOR
Sontek Industries, Inc.
ILQ
Feb 4, 1981K802687SPEAKEASY COMMUN. SYSTEM-COMM. PROTHESIS
Intelligent Software Systems, Inc.
ILQ
Oct 6, 1977K771825CARBA LINGUARDUC
C.R. Bard, Inc.
ILQ
Jan 12, 1977K770031ALARM INTERCOM DOOR LOCK
Possum, Inc.
ILQ
Jan 12, 1977K770030ALARM, COMMUN.-SEC. INDEP.-EMER.
Possum, Inc.
ILQ
Jan 12, 1977K770029TYPEWRITER CONTROL SYSTEMS
Possum, Inc.
ILQ

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