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510(k) K915629

Device
CUSHION, WHELCHAR AND FLOTATION
Applicant
INVACARE CORP.
510(k) number
K915629
Product code
KNN  
Decision
Substantially Equivalent (SESE)
Decision date
1992-01-09
Date received
1991-12-17
Regulation
890.3920
Classification name
Components, Wheelchair
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
EDWARD KROLL
Address
899 Cleveland St. P.O. Box 4028 Elyria OH US 44036 44036

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KNN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K211919KISS Dynamic Back Support, KISS Dynamic Solid Drop SeatKinetic Innovative Seating System, LLC2022-03-04
K942311DYNASTY U1-33 AGMFoley & Lardner1994-11-07
K942310DYNASTY GC 12550 (GELL/CELL)Foley & Lardner1994-11-07
K942309DYNASTY U1-31 (GELL/CELL)Foley & Lardner1994-11-07
K942308DYNASTY GC 12400 (GELL/CELL)Foley & Lardner1994-11-07
K942260ALDEN WHEELCHAIR CUSHIONWard and Assoc.1994-05-26
K942312ALDEN LINEAGE WHEELCHAIR CUSHIONLewis W. Ward1994-05-26
K933051ZERO GRAVITY WHEELCHAIR COMPONENTS, MODIFICATIONGeneral Components Intl., Inc.1993-10-12
K925980PMPathfinder Intl. Corp.1993-03-24
K923942RHOMBO MEDICAL RHOMBO-FILLInternational Medical Products, Inc.1993-03-24
K923364TILT ADJUSTABLE SLIDING BACK RECLINE SEATING SYSTLabac Systems, Inc.1993-03-22
K925336VALU-PLUS PADValmed, Inc.1993-02-12
K923366TILT SEATING SYSTEMLabac Systems, Inc.1993-02-12
K923186NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTICRoho, Inc.1992-09-09
K921369BIOMEDICAL HORIZONS MODEL 1001Biomedical Horizons, Inc.1992-05-11

Legacy Summary#

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FDA Review#

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