IQA — System, Environmental Control, Powered Class II
FDA product code IQA covers "System, Environmental Control, Powered", a Class II medical device regulated under 21 CFR 890.3725. Submissions are reviewed by the Physical Medicine panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IQA
- Device Class
- Class II
- Regulation Number
- 890.3725
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K961306 | prentke romich | DELTATALKER WITH INFRARED | June 27, 1996 |
| K953905 | teledyne brown engineering | IMPERIUM | November 21, 1995 |
| K953937 | apt technology | LIAISON COMPUTER ACCESS & ENVIRONMENTAL CONTROL SYSTEM | October 31, 1995 |
| K943244 | apt technology | DEUCE | September 11, 1995 |
| K944585 | prentke romich | SCANNING DIRECTOR | February 21, 1995 |
| K944345 | trac medical | BEDSIDE BUTLER | October 17, 1994 |
| K940223 | interactive technologies | LEARN MODE WATERPROOF PENDANT PANIC BUTTON | April 29, 1994 |
| K926029 | zygo industries | INFRA-LINK | March 26, 1993 |
| K921528 | hill-rom | HILL-ROM PATIENT ENVIRONMENTAL CONTROL SYSTEM | April 20, 1992 |
| K911101 | zofcom | TONGUETOUCH KEYPAD AND ZOFCOM CONTROL SYSTEM | April 25, 1991 |
| K902664 | prentke romich | HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1 | July 25, 1990 |
| K900969 | baylor biomedical services | REMOTE CONTROL SWITCH | March 13, 1990 |
| K901028 | baylor biomedical services | ENVIRONMENTAL CONTROL UNIT MODEL 7000 | March 13, 1990 |
| K890596 | silent call | MED-A-CALL ASSIST DEVICE | March 14, 1989 |
| K881634 | quartet technology | SIMPLICITY SERIES 5 | May 17, 1988 |
| K873612 | intl. management services | IMSI, VITAL CALL | November 23, 1987 |
| K872937 | j. h. emerson | 97-TD EMERSON TIMER/DIMMER CONTROL | September 24, 1987 |
| K872936 | j. h. emerson | 97-D EMERSON DIMMER CONTROL | September 24, 1987 |
| K851740 | independent living | EZZIE SYSTEM | July 15, 1985 |
| K850313 | rehab technology | TELEVISION CONTROL OPTION 1219 | April 25, 1985 |