Product code IQA

Device name: System, Environmental Control, Powered
Medical specialty: Physical Medicine
Device class: 2
Regulation number: 890.3725
Review panel: PM
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K961306	DELTATALKER WITH INFRARED	Prentke Romich Co.	1996-06-27
K953905	IMPERIUM	Teledyne Brown Engineering	1995-11-21
K953937	LIAISON COMPUTER ACCESS & ENVIRONMENTAL CONTROL SYSTEM	Apt Technology, Inc.	1995-10-31
K943244	DEUCE	Apt Technology, Inc.	1995-09-11
K944585	SCANNING DIRECTOR	Prentke Romich Co.	1995-02-21
K944345	BEDSIDE BUTLER	Trac Medical, Inc.	1994-10-17
K940223	LEARN MODE WATERPROOF PENDANT PANIC BUTTON	Interactive Technologies, Inc.	1994-04-29
K926029	INFRA-LINK	Zygo Industries, Inc.	1993-03-26
K921528	HILL-ROM PATIENT ENVIRONMENTAL CONTROL SYSTEM	Hill-Rom, Inc.	1992-04-20
K911101	TONGUETOUCH KEYPAD AND ZOFCOM CONTROL SYSTEM	Zofcom, Inc.	1991-04-25
K902664	HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1	Prentke Romich Co.	1990-07-25
K900969	REMOTE CONTROL SWITCH	Baylor Biomedical Services	1990-03-13
K901028	ENVIRONMENTAL CONTROL UNIT MODEL 7000	Baylor Biomedical Services	1990-03-13
K890596	MED-A-CALL ASSIST DEVICE	Silent Call Corp.	1989-03-14
K881634	SIMPLICITY SERIES 5	Quartet Technology, Inc.	1988-05-17
K873612	IMSI, VITAL CALL	Intl. Management Services, Inc.	1987-11-23
K872936	97-D EMERSON DIMMER CONTROL	J. H. Emerson Co.	1987-09-24
K872937	97-TD EMERSON TIMER/DIMMER CONTROL	J. H. Emerson Co.	1987-09-24
K851740	EZZIE SYSTEM	Independent Living, Inc.	1985-07-15
K850313	TELEVISION CONTROL OPTION 1219	Rehab Technology, Inc.	1985-04-25
K850314	TELEVISION CONTROL OPTION 1220	Rehab Technology, Inc.	1985-04-25
K840808	ECU 1218	Rehab Technology, Inc.	1984-03-19
K832057	NURSE CALL BUTTON	Qa Alert Systems	1983-07-12
K770028	ENVIRONMENTAL CONTROL SYSTEMS	Possum, Inc.	1977-01-12

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00812664025127	TekTone Sound & Signal Mfg., Inc.	TEKTONE SOUND AND SIGNAL, MFG., INC.	2026-08-19
00812664024700	TekTone Sound & Signal Mfg., Inc.	TEKTONE SOUND AND SIGNAL, MFG., INC.	2026-08-18
00840828197007	GEN4 INTERACTIVE	CURBELL MEDICAL PRODUCTS, INC.	2026-08-18
00812664025141	TekTone Sound & Signal Mfg., Inc.	TEKTONE SOUND AND SIGNAL, MFG., INC.	2026-08-18
00812664025134	TekTone Sound & Signal Mfg., Inc.	TEKTONE SOUND AND SIGNAL, MFG., INC.	2026-08-18
00812664024915	TekTone Sound & Signal Mfg., Inc.	TEKTONE SOUND AND SIGNAL, MFG., INC.	2026-08-18
00812664024908	TekTone Sound & Signal Mfg., Inc.	TEKTONE SOUND AND SIGNAL, MFG., INC.	2026-08-18
00812664024892	TekTone Sound & Signal Mfg., Inc.	TEKTONE SOUND AND SIGNAL, MFG., INC.	2026-08-18
00812664024731	TekTone Sound & Signal Mfg., Inc.	TEKTONE SOUND AND SIGNAL, MFG., INC.	2026-08-18
00812664024724	TekTone Sound & Signal Mfg., Inc.	TEKTONE SOUND AND SIGNAL, MFG., INC.	2026-08-18
00812664024717	TekTone Sound & Signal Mfg., Inc.	TEKTONE SOUND AND SIGNAL, MFG., INC.	2026-08-18
00840828196864	GEN4 DIRECT ACCESS	CURBELL MEDICAL PRODUCTS, INC.	2026-07-23
00840828196871	GEN4 INTERACTIVE	CURBELL MEDICAL PRODUCTS, INC.	2026-07-23
00840828196840	GEN4 DIGITAL	CURBELL MEDICAL PRODUCTS, INC.	2026-07-08
00840828196833	GEN4 INTERACTIVE	CURBELL MEDICAL PRODUCTS, INC.	2026-07-08
00840828196796	GEN4 INTERACTIVE	CURBELL MEDICAL PRODUCTS, INC.	2026-07-08
00840828196826	GEN4 INTERACTIVE	CURBELL MEDICAL PRODUCTS, INC.	2026-07-08
00840828196819	GEN4 INTERACTIVE	CURBELL MEDICAL PRODUCTS, INC.	2026-07-08
00840828196802	GEN4 INTERACTIVE	CURBELL MEDICAL PRODUCTS, INC.	2026-07-08
00840828196789	GEN4 INTERACTIVE	CURBELL MEDICAL PRODUCTS, INC.	2026-07-08
00840828196758	GEN4 INTERACTIVE	CURBELL MEDICAL PRODUCTS, INC.	2026-07-08
00840828196666	GEN4 INTERACTIVE	CURBELL MEDICAL PRODUCTS, INC.	2026-06-09
00840828196673	GEN4 INTERACTIVE	CURBELL MEDICAL PRODUCTS, INC.	2026-06-09
00840828196475	GEN4 INTERACTIVE	CURBELL MEDICAL PRODUCTS, INC.	2026-05-27
00840828196482	GEN4 INTERACTIVE	CURBELL MEDICAL PRODUCTS, INC.	2026-05-27
00840828196499	GEN4 INTERACTIVE	CURBELL MEDICAL PRODUCTS, INC.	2026-05-27
00840828196505	GEN4 INTERACTIVE	CURBELL MEDICAL PRODUCTS, INC.	2026-05-27
00840828196512	GEN4 INTERACTIVE	CURBELL MEDICAL PRODUCTS, INC.	2026-05-27
00840828196529	GEN4 INTERACTIVE	CURBELL MEDICAL PRODUCTS, INC.	2026-05-27
00840828196536	GEN4 INTERACTIVE	CURBELL MEDICAL PRODUCTS, INC.	2026-05-27

Product code IQA

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