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510(k) K830427

Device
ARM CUSHION
Applicant
MADDAK, INC.
510(k) number
K830427
Product code
KIC  
Decision
Substantially Equivalent (SESE)
Decision date
1983-03-29
Date received
1983-02-09
Regulation
890.3175
Classification name
Cushion, Flotation
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KIC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K960189GEL-T CUSHIONSpan-America Medical Systems, Inc.1996-02-07
K953352PROTEAM CUSHIONIskra.Med1995-11-29
K954117CUSTOMCARE SEATING SYSTEMSpan-America Medical Systems, Inc.1995-10-13
K950085MULTICURE(R) S GEL PADMultigestion (Deutschland) GmbH1995-07-13
K945667MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHIONMicos Medical Systems1995-02-21
K941858GEL CUSHIONHollister, Inc.1994-05-05
K911843ZERO-G(TM) GEL/FOAM MATTRESS TOPPERSteridyne Corp.1991-05-30
K872739SAFE-SEAT, LOW-PROFILE WHEELCHAIR CUSHIOND.A. Schulman, Inc.1987-07-30
K864109C' AIRECUSH SEAT CUSHIONMedical Industries America, Inc.1986-11-14
K864108PUSH CUSHMedical Industries America, Inc.1986-11-14
K861327ROHO HEEL PADRoho, Inc.1986-06-02
K855072MAXIMUS CUSHIONJay Medical, Ltd.1986-03-10
K851814WHEELCHAIR CUSHIONSDignicare1985-07-09
K851027SOF. CARE CUSHION & SOF-CARE CUSHION COVERGaymar Industries, Inc.1985-06-18
K842380PRESSURE RELIEF SEAT CUSHIONAmerican Pharmaseal Div. Ahsc1984-06-28

Legacy Summary#

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FDA Review#

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