Atlas FDA

IQA

24 FDA 510(k) clearances · Product code

59 daysmedian time to decision
115 days90th percentile
24clearances measured

FDA profile

Official device name
System, Environmental Control, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 890.3725
Medical specialty
Physical Medicine
Adverse events (MAUDE)
2023: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
DELTATALKER WITH INFRARED (K961306)Prentke Romich Co.1996-06-27
IMPERIUM (K953905)Teledyne Brown Engineering1995-11-21
LIAISON COMPUTER ACCESS & ENVIRONMENTAL CONTROL SYSTEM (K953937)Apt Technology, Inc.1995-10-31
DEUCE (K943244)Apt Technology, Inc.1995-09-11
SCANNING DIRECTOR (K944585)Prentke Romich Co.1995-02-21
BEDSIDE BUTLER (K944345)Trac Medical, Inc.1994-10-17
LEARN MODE WATERPROOF PENDANT PANIC BUTTON (K940223)Interactive Technologies, Inc.1994-04-29
INFRA-LINK (K926029)Zygo Industries, Inc.1993-03-26
HILL-ROM PATIENT ENVIRONMENTAL CONTROL SYSTEM (K921528)Hill-Rom, Inc.1992-04-20
TONGUETOUCH KEYPAD AND ZOFCOM CONTROL SYSTEM (K911101)Zofcom, Inc.1991-04-25
HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1 (K902664)Prentke Romich Co.1990-07-25
ENVIRONMENTAL CONTROL UNIT MODEL 7000 (K901028)Baylor Biomedical Services1990-03-13
REMOTE CONTROL SWITCH (K900969)Baylor Biomedical Services1990-03-13
MED-A-CALL ASSIST DEVICE (K890596)Silent Call Corp.1989-03-14
SIMPLICITY SERIES 5 (K881634)Quartet Technology, Inc.1988-05-17
IMSI, VITAL CALL (K873612)Intl. Management Services, Inc.1987-11-23
97-D EMERSON DIMMER CONTROL (K872936)J. H. Emerson Co.1987-09-24
97-TD EMERSON TIMER/DIMMER CONTROL (K872937)J. H. Emerson Co.1987-09-24
EZZIE SYSTEM (K851740)Independent Living, Inc.1985-07-15
TELEVISION CONTROL OPTION 1219 (K850313)Rehab Technology, Inc.1985-04-25
TELEVISION CONTROL OPTION 1220 (K850314)Rehab Technology, Inc.1985-04-25
ECU 1218 (K840808)Rehab Technology, Inc.1984-03-19
NURSE CALL BUTTON (K832057)Qa Alert Systems1983-07-12
ENVIRONMENTAL CONTROL SYSTEMS (K770028)Possum, Inc.1977-01-12

Track IQA automatically

Every clearance here is in the API, with alerts when new ones post.