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510(k) K950656

Device
PED ALERT
Applicant
ORBITEC TECHNOLOGIES CORP.
510(k) number
K950656
Product code
IRN  
Decision
Substantially Equivalent (SESE)
Decision date
1995-10-25
Date received
1995-02-13
Regulation
890.5575
Classification name
Device, Warning, Overload, External Limb, 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 M CRABB
Address
402 Gammon Pl. Suite 200 Madison WI US 53719 53719

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IRN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K060150SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEMAndante Medical Devices , Ltd.2006-02-23
K023161SMARTSTEP SYSTEMAndante Medical Device, Ltd.2002-12-10
K991313ACCUTRED SHOEOrthopedic Technology Research, Inc.1999-06-23
K962591FOOT WEIGHT ALARMCleveland Medical Devices, Inc.1996-12-04
K960307INDEX SHOEOrthopedic Technology Research, Inc.1996-06-27
K955034FORCEGUARDImpact Monitors, Inc.1996-04-10
K931517SAFE-STEPLenjoy Engineering, Inc.1995-03-10
K882974FORCE GUARD IBoulder Impact Monitors, Inc.1988-11-04
K792241PELIMITColmed, Ltd.1979-11-30
K770405OVERLOAD WARNING DEVICESynthes (Usa)1977-03-10

Legacy Summary#

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FDA Review#

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