Product code IKZ— Physical Medicine
CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM
- Classification name
- Bed, Patient Rotation, Powered
- Device class
- Class 2
- Regulation
- 21 CFR 890.5225
- Advisory panel
- Physical Medicine
- Total cleared
- 17
- First cleared
- Most recent
Market context for product code IKZ
FDA has cleared devices under product code IKZ between 1981 and 1998, filed by 14 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1998
- 1997
- 1996
- 1995
- 1994
- 1993
- 1992
- 1991
- 1990
- 1987
- 1984
- 1982
- 1981
Top applicants under product code IKZ
Recent clearances under product code IKZ
- K972486 — PRESSUREGUARD IV
- K972111 — RUMORS DYNAMIC AIR THERAPY UNIT
- K962788 — CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM
- K954671 — THE FREEDOM BED
- K950756 — PULMONEX DYNAMIC AIR THERAPY UNIT
- K950681 — MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY
- K933964 — THE CRADLE
- K923710 — OSCILLAIR 3000 LOW AIR LOSS KINETIC THERAPY BED
- K922473 — TURN EZ BED DEVICE
- K905390 — KUDO (POWERED ROTATION BED)
- K905113 — ROTO REST; TRAUMA AND INTENSIVE CARE BED
- K873047 — KEANE MOBILITY BED
- K842604 — EMERSON MOTION BED 6-MS & 6-ME
- K834563 — EGERTON TURNING & TILTING BED
- K823095 — KINETIC MOTION BED
- K822402 — ROTO REST KINETIC TREATMENT TABLE PEDIA
- K810220 — POWERED PATIENT SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.