FDA.reportPublic FDA data

510(k) K010644

Device
CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025
Applicant
Skil-Care Corp.
510(k) number
K010644
Product code
FMQ
Decision
Substantially Equivalent (SESE)
Decision date
2001-05-18
Date received
2001-03-05
Regulation
880.6760
Classification name
Restraint, Protective
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
ARNOLD SILVERMAN
Address
29 Wells Ave. Yonkers NY US 10701 10701

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K110377PROTECTIVE RESTRAINTMedi-Tech Intl. Corp.2011-04-25
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K080448CENTURION PROTECTIVE RESTRAINT, SCR SERIESTri-State Hospital Supply Corp.2008-08-28
K013239COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLESMed Gen, Inc.2001-11-20
K010818INFANT LIMB HOLDER, MODELS 306080 & 306081Skil-Care Corp.2001-05-24
K991591BIOTHANE PATIENT RESTRAINTBioplastics1999-07-29
K982178VAGABOND SOFT RESTRAINT SYSTEMEmergent Innovations, Ltd.1999-01-26
K980640HEELBO WAIST AND CHEST VESTHeelbo, Inc.1998-05-01
K972446PEDO CUSH PEDO CUDDLECavity Free Kids, Inc.1997-11-13
K972046FULL BODY RESTRAINT SYSTEMGillen Industries1997-08-15
K971948PATIENT RESTRAINTE.M. Adams Co., Inc.1997-08-06
K972123PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905Smith1997-07-25
K971742DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINTDepuy, Inc.1997-07-24
K972338PROTECTIVE RESTRAINT(MODELS #302,440,750 AND A30 X 30 BELT.Geriatric Products, Inc.1997-07-24
K971561PROVEST-PROTECTIVE RESTRAINTJemm Medical Products1997-07-14