Product code INX— Physical Medicine
AIR PLUS AIR FLUIDIZED THERAPY SYSTEMS
- Classification name
- Bed, Air Fluidized
- Device class
- Class 2
- Regulation
- 21 CFR 890.5160
- Advisory panel
- Physical Medicine
- Total cleared
- 28
- First cleared
- Most recent
Market context for product code INX
FDA has cleared devices under product code INX between 1976 and 1998, filed by 23 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
last 15 years- 1998
- 1997
- 1995
- 1994
- 1993
- 1992
- 1991
- 1990
- 1989
- 1988
- 1987
- 1985
- 1984
- 1982
- 1981
Top applicants under product code INX
Recent clearances under product code INX
- K972176 — HOME CARE BEAD BED
- K964223 — CLINITRON RITE-HITE
- K943385 — CLINITRON ELEXIS
- K942184 — CLINITRON AT HOME AIR FLUIDED THERAPY
- K931168 — X-20 AIR SUPPORT BED
- K934689 — LOW AIR LOSS MATTRESS, MODIFICATION
- K924973 — DYLNAMEDICS A.S.A.P.
- K926402 — COMFORT CARE LOW AIR LOSS THERAPY BED
- K924686 — REM-AIR
- K920112 — CLINITRON C-II
- K913654 — SMITH AND DAVIS PRESSURE THERAPY SYSTEM
- K911246 — THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 2
- K911057 — DERMATEK 4000
- K904008 — STAGE IV, AIR-FLUIDIZE BED
- K890523 — SUPERCAIR
- K884835 — TASSI MK2
- K884529 — MICROAIR FLUIDIZED AIR BED
- K881917 — FLUIDAIR
- K881705 — MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM
- K880340 — MODIFIED AIR FLUIDIZED BED, KINAIR
- K870045 — SKYTRON MODEL 610-2
- K852036 — AIR PLUS AIR FLUIDIZED THERAPY SYSTEMS
- K843389 — CLINITRON AIR FLUIDIZED SUPPORT J-101UD
- K842987 — APOLLO AIR FLUIDIZED BED
- K834344 — MED-OPEDIC SLEEP SYSTEM
- K813584 — CLINITRON AIR FLUIDIZED SUPPORT SYSTEM
- K810543 — NEO-WAVE SYSTEM
- K760712 — MEDISCUS AIR BED
Data sourced from openFDA. This site is unofficial and independent of the FDA.