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510(k) K941610

Device
Clensicair Low Airloss Hydrotherapy
Applicant
SUPPORT SYSTEMS INTL.
510(k) number
K941610
Product code
IOQ
Decision
Substantially Equivalent (SESE)
Decision date
1995-02-10
Date received
1994-03-31
Regulation
890.5170
Classification name
Bed, Flotation Therapy, Powered
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
THOMAS MCFADDEN
Address
4349 Corporate Rd. Charleston SC US 29405 29405

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IOQ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K143414Hill-Rom Wireless Connectivity ModuleHill-Rom2015-03-10
K122473TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2Hill-Rom2013-06-03
K973624NURSE'S AID PATIENT ROTATION SYSTEMAir Med Assist Products1998-01-21
K970364AIRTEC2 LOW AIR LOSS THERAPY BEDApex Metal, Inc.1997-11-17
K970363HYDROTEC LOW AIR LOSS THERAPY BEDApex Metal, Inc.1997-11-17
K970636TOTALCARE., MODULAR THERAPY SYSTEM (MTS)Hill-Rom, Inc.1997-08-26
K964873SILKAIR LOW AIRLOSS THERAPYHill-Rom, Inc.1997-07-03
K970295FLEXICAIR EXLIPSE PLUSHill-Rom, Inc.1997-05-16
K943433TOTAL CONTACT SEAT RIPPLE SYSTEMNumotech, Inc.1995-07-31
K951001FLEXICAIR EXLIPSEHill-Rom, Inc.1995-06-27
K945729DYNAMICAIRE(TM) SLEEP SURFACE, ZONEAIR(TM) SLEEP SURFACEHill-Rom, Inc.1995-02-27
K940662I-5000Support Systems Intl.1994-06-15
K931594THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEMMedical Device Inspection Co., Inc.1993-12-21
K932480PRISMBio Clinic Co.1993-07-21
K926189ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALEBio Clinic Co.1993-06-24