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510(k) K801625

Device
THERMOLATOR HEATING UNIT
Applicant
TRU-EZE MFG. CO., INC.
510(k) number
K801625
Product code
IRQ  
Decision
Substantially Equivalent (SESE)
Decision date
1980-07-28
Date received
1980-07-15
Regulation
890.5950
Classification name
Unit, Heating, Powered
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 IRQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K050524EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000Marda Medical, Inc.2005-09-14
K950350THEMALATOR. MODELS T-4-S, T-8-S, ETC.Whitehall/Div Columbus Mckennon Corp.1995-03-24
K924023FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917Ferno1993-04-14
K880644ULTRA-PAN FOR ORTHOTIC PLASTICS (7262)Fred Sammons, Inc.1988-05-06
K861340R1750 AND R1424 POWERED HEATING UNITSTri W-G, Inc.1986-05-02
K832177PULSAIR MODEL SP-1Thermowave Medical Device Corp.1983-12-09

Legacy Summary#

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FDA Review#

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