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
Related 510(k) Records#
| 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 |
| K901028 | ENVIRONMENTAL CONTROL UNIT MODEL 7000 | Baylor Biomedical Services | 1990-03-13 |
| K900969 | REMOTE CONTROL SWITCH | 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 |
| K872937 | 97-TD EMERSON TIMER/DIMMER CONTROL | J. H. Emerson Co. | 1987-09-24 |
| K872936 | 97-D EMERSON DIMMER CONTROL | J. H. Emerson Co. | 1987-09-24 |
| K851740 | EZZIE SYSTEM | Independent Living, Inc. | 1985-07-15 |
| K850314 | TELEVISION CONTROL OPTION 1220 | Rehab Technology, Inc. | 1985-04-25 |
| K850313 | TELEVISION CONTROL OPTION 1219 | 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840828196482 | GEN4 INTERACTIVE | CURBELL MEDICAL PRODUCTS, INC. | 2026-05-27 |
| 00840828196659 | GEN4 INTERACTIVE | CURBELL MEDICAL PRODUCTS, INC. | 2026-05-27 |
| 00840828196642 | GEN4 INTERACTIVE | CURBELL MEDICAL PRODUCTS, INC. | 2026-05-27 |
| 00840828196635 | GEN4 INTERACTIVE | CURBELL MEDICAL PRODUCTS, INC. | 2026-05-27 |
| 00840828196628 | GEN4 INTERACTIVE | CURBELL MEDICAL PRODUCTS, INC. | 2026-05-27 |
| 00840828196611 | GEN4 INTERACTIVE | CURBELL MEDICAL PRODUCTS, INC. | 2026-05-27 |
| 00840828196604 | GEN4 INTERACTIVE | CURBELL MEDICAL PRODUCTS, INC. | 2026-05-27 |
| 00840828196598 | GEN4 INTERACTIVE | CURBELL MEDICAL PRODUCTS, INC. | 2026-05-27 |
| 00840828196581 | GEN4 INTERACTIVE | CURBELL MEDICAL PRODUCTS, INC. | 2026-05-27 |
| 00840828196574 | GEN4 INTERACTIVE | CURBELL MEDICAL PRODUCTS, INC. | 2026-05-27 |
| 00840828196550 | GEN4 INTERACTIVE | CURBELL MEDICAL PRODUCTS, INC. | 2026-05-27 |
| 00840828196543 | GEN4 INTERACTIVE | CURBELL MEDICAL PRODUCTS, INC. | 2026-05-27 |
| 00840828196536 | GEN4 INTERACTIVE | CURBELL MEDICAL PRODUCTS, INC. | 2026-05-27 |
| 00840828196529 | GEN4 INTERACTIVE | CURBELL MEDICAL PRODUCTS, INC. | 2026-05-27 |
| 00840828196512 | GEN4 INTERACTIVE | CURBELL MEDICAL PRODUCTS, INC. | 2026-05-27 |
| 00840828196505 | GEN4 INTERACTIVE | CURBELL MEDICAL PRODUCTS, INC. | 2026-05-27 |
| 00840828196499 | GEN4 INTERACTIVE | CURBELL MEDICAL PRODUCTS, INC. | 2026-05-27 |
| 00840828196475 | GEN4 INTERACTIVE | CURBELL MEDICAL PRODUCTS, INC. | 2026-05-27 |
| 00840828196567 | GEN4 INTERACTIVE | CURBELL MEDICAL PRODUCTS, INC. | 2026-05-27 |
| 17350088671396 | Ascom | Ascom (Sweden) AB | 2023-01-09 |
| 17350088670818 | Ascom | Ascom (Sweden) AB | 2022-09-16 |
| 00812664023710 | KIT, PANEL, PL691, 5-PCS | Securitas Healthcare LLC | 2021-07-10 |
| 00812664022133 | "DUMMY PLUG, 1/4"" PLASTIC - 5 EA" | Securitas Healthcare LLC | 2021-07-10 |
| 00840828180245 | GEN4 INTERACTIVE | CURBELL MEDICAL PRODUCTS, INC. | 2020-05-12 |
| 00840828180238 | GEN4 INTERACTIVE | CURBELL MEDICAL PRODUCTS, INC. | 2020-05-12 |
| 17350088670481 | ASCOM | Ascom (Sweden) AB | 2019-08-19 |
| 17350088670597 | Ascom | Ascom (Sweden) AB | 2017-08-28 |
| XL01YRRSXXXZZZ10 | Excel Digital | Crest Healthcare Supply | 2017-01-25 |
| XN15CCEIXXXXTAAYL0 | Elite Digital | Crest Healthcare Supply | 2017-01-24 |
| XN08CCEIXXXXTAAYL0 | Elite Digital | Crest Healthcare Supply | 2017-01-24 |