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510(k) K992372

Device
THE LEADAWAY
Applicant
THERAPY EQUIPMENT, INC.
510(k) number
K992372
Product code
IKD  
Decision
Substantially Equivalent (SESE)
Decision date
1999-10-13
Date received
1999-07-15
Regulation
890.1175
Classification name
Cable, Electrode
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
GLENN BUCHAN
Address
13860 Wellington Trace, #310 West Palm Beach FL US 33414 33414

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IKD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K070926ELECTRODE/EXTENSION CABLES, MODELS ATAROscor, Inc.2007-06-07
K935260PHYSIOMETRIX CABLE ADAPTER MODIFICATIONPhysiometrix, Inc.1993-12-23
K873361LIFE-SPAN CABLEChemfet Corp.1987-11-09
K834583CLEAR LEADS-RADIOTRANSPARENT WIRESQuinton, Inc.1984-01-30
K800934R2 ESU CABLE-ADAPTER MODELS 160,161R2 Corp.1980-05-20

Legacy Summary#

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FDA Review#

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