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510(k) K823160

Device
ROTATION BOOT
Applicant
WARM & FORM, ORTHOPEDIC MATERIALS
510(k) number
K823160
Product code
IQI  
Decision
Substantially Equivalent (SESE)
Decision date
1982-11-10
Date received
1982-10-25
Regulation
890.3475
Classification name
Orthosis, Limb Brace
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IQI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K143458NeurosplintNeurospectrum, LLC2015-08-13
K052771SENSOR WALKOtto Bock Healthcare LP2006-05-03
K031576SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1Surgitech, Inc.2003-07-31
K926391ACCUFLEX DYNAMIC ELBOW ORTHOSISRegulatory & Marketing Services, Inc.1993-07-22
K910974MCCONNELL SHOULDER BRACEMcconnell Orthopedic1991-03-21
K874502GAIT-AID ORTHOPEDIC INSOLEGait-Aid, Inc.1987-11-30
K831542ADJUSTABLE POLYCENTRIC ELBOW HINGEFred Sammons, Inc.1983-06-24
K831615DROP FOOT BRACEEdward Dilauro, Jr.1983-06-15
K823812VARIOUS SUPPORTS AND SPLINTSDanek Medical, Inc.1983-01-14
K823113BRACE-UP ALL PURPOSE WRIST BANDArco Matic, Inc.1982-11-16
K823114BRACE-UP STOCKING KNEE BRACEArco Matic, Inc.1982-11-05
K822767UNIVERSAL DYNASPLINTDynasplint Systems, Inc.1982-10-06
K822022SPORT SUPPORTSGinny, Inc.1982-07-26
K821704FRACTURE BRACINGHosmer Dorrance Corp.1982-06-24
K821640ORTHOTIC FABRICATION ACCESSORIESFred Sammons, Inc.1982-06-11

Legacy Summary#

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FDA Review#

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