IOQ — Bed, Flotation Therapy, Powered Class II
FDA product code IOQ covers "Bed, Flotation Therapy, Powered", a Class II medical device regulated under 21 CFR 890.5170. 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
- IOQ
- Device Class
- Class II
- Regulation Number
- 890.5170
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K143414 | hill-rom | Hill-Rom Wireless Connectivity Module | March 10, 2015 |
| K122473 | hill-rom | TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE | June 3, 2013 |
| K973624 | air med assist products | NURSE'S AID PATIENT ROTATION SYSTEM | January 21, 1998 |
| K970364 | apex metal | AIRTEC2 LOW AIR LOSS THERAPY BED | November 17, 1997 |
| K970363 | apex metal | HYDROTEC LOW AIR LOSS THERAPY BED | November 17, 1997 |
| K970636 | hill-rom | TOTALCARE., MODULAR THERAPY SYSTEM (MTS) | August 26, 1997 |
| K964873 | hill-rom | SILKAIR LOW AIRLOSS THERAPY | July 3, 1997 |
| K970295 | hill-rom | FLEXICAIR EXLIPSE PLUS | May 16, 1997 |
| K943433 | numotech | TOTAL CONTACT SEAT RIPPLE SYSTEM | July 31, 1995 |
| K951001 | hill-rom | FLEXICAIR EXLIPSE | June 27, 1995 |
| K945729 | hill-rom | DYNAMICAIRE(TM) SLEEP SURFACE, ZONEAIR(TM) SLEEP SURFACE | February 27, 1995 |
| K941610 | support systems intl | CLENSICAIR LOW AIRLOSS HYDROTHERAPY | February 10, 1995 |
| K940662 | support systems intl | I-5000 | June 15, 1994 |
| K931594 | medical device inspection co | THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM | December 21, 1993 |
| K932480 | bio clinic | PRISM | July 21, 1993 |
| K926189 | bio clinic | ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALE | June 24, 1993 |
| K925694 | gsi medical systems | MICROAIR PUP | March 24, 1993 |
| K926456 | gsi development | MICROAIR TURN-Q | March 24, 1993 |
| K923977 | lumex | AKROTECH 4000 | February 12, 1993 |
| K922973 | support systems intl | RESTCUE CC | July 30, 1992 |