IQA · Class II · 21 CFR 890.3725

FDA Product Code IQA: System, Environmental Control, Powered

Leading manufacturers include Rehab Technology, Inc., Prentke Romich Co. and Apt Technology, Inc..

24
Total
24
Cleared
75d
Avg days
1977
Since

FDA 510(k) Cleared System, Environmental Control, Powered Devices (Product Code IQA)

24 devices
1–24 of 24
Cleared Jun 27, 1996
DELTATALKER WITH INFRARED
K961306
Prentke Romich Co.
Physical Medicine · 84d
Cleared Nov 21, 1995
IMPERIUM
K953905
Teledyne Brown Engineering
Physical Medicine · 95d
Cleared Oct 31, 1995
LIAISON COMPUTER ACCESS & ENVIRONMENTAL CONTROL SYSTEM
K953937
Apt Technology, Inc.
Physical Medicine · 74d
Cleared Sep 11, 1995
DEUCE
K943244
Apt Technology, Inc.
Physical Medicine · 432d
Cleared Feb 21, 1995
SCANNING DIRECTOR
K944585
Prentke Romich Co.
Physical Medicine · 155d
Cleared Oct 17, 1994
BEDSIDE BUTLER
K944345
Trac Medical, Inc.
Physical Medicine · 41d
Cleared Apr 29, 1994
LEARN MODE WATERPROOF PENDANT PANIC BUTTON
K940223
Interactive Technologies, Inc.
Physical Medicine · 101d
Cleared Mar 26, 1993
INFRA-LINK
K926029
Zygo Industries, Inc.
Physical Medicine · 115d
Cleared Apr 20, 1992
HILL-ROM PATIENT ENVIRONMENTAL CONTROL SYSTEM
K921528
Hill-Rom, Inc.
Physical Medicine · 18d
Cleared Apr 25, 1991
TONGUETOUCH KEYPAD AND ZOFCOM CONTROL SYSTEM
K911101
Zofcom, Inc.
Physical Medicine · 43d
Cleared Jul 25, 1990
HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1
K902664
Prentke Romich Co.
Physical Medicine · 37d
Cleared Mar 13, 1990
REMOTE CONTROL SWITCH
K900969
Baylor Biomedical Services
Physical Medicine · 11d
Cleared Mar 13, 1990
ENVIRONMENTAL CONTROL UNIT MODEL 7000
K901028
Baylor Biomedical Services
Physical Medicine · 7d
Cleared Mar 14, 1989
MED-A-CALL ASSIST DEVICE
K890596
Silent Call Corp.
Physical Medicine · 46d
Cleared May 17, 1988
SIMPLICITY SERIES 5
K881634
Quartet Technology, Inc.
Physical Medicine · 33d
Cleared Nov 23, 1987
IMSI, VITAL CALL
K873612
Intl. Management Services, Inc.
Physical Medicine · 76d
Cleared Sep 24, 1987
97-D EMERSON DIMMER CONTROL
K872936
J. H. Emerson Co.
Physical Medicine · 59d
Cleared Sep 24, 1987
97-TD EMERSON TIMER/DIMMER CONTROL
K872937
J. H. Emerson Co.
Physical Medicine · 59d
Cleared Jul 15, 1985
EZZIE SYSTEM
K851740
Independent Living, Inc.
Physical Medicine · 77d
Cleared Apr 25, 1985
TELEVISION CONTROL OPTION 1219
K850313
Rehab Technology, Inc.
Physical Medicine · 90d
Cleared Apr 25, 1985
TELEVISION CONTROL OPTION 1220
K850314
Rehab Technology, Inc.
Physical Medicine · 90d
Cleared Mar 19, 1984
ECU 1218
K840808
Rehab Technology, Inc.
Physical Medicine · 24d
Cleared Jul 12, 1983
NURSE CALL BUTTON
K832057
Qa Alert Systems
Physical Medicine · 15d
Cleared Jan 12, 1977
ENVIRONMENTAL CONTROL SYSTEMS
K770028
Possum, Inc.
Physical Medicine · 6d

About Product Code IQA - Regulatory Context