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Data / Medical devices / United States / Carematix Inc.

Carematix Inc.: FDA-registered device maker in Chicago, IL, United States, 5 510(k) clearances

Carematix Inc. is registered with the FDA (registration 3003982635) in Chicago, IL, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated November 28, 2012. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number
3003982635
Address
1 N LaSalle St Suite 4400, Chicago, IL, United States, 60602
Owner or operator
CAREMATIX INC. (9053352)
Roles
Manufacturer, Specification developer
First device listed
March 11, 2008
Registered through
2027
Brand names listed
Blip WiFi Weight Scale WS5500-WF, Carematix Wellness System

Devices it lists

DeviceProduct codeClassRoleSource
Scale, Stand-On, PatientFRI1Specification developeraccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Manufacturer, Specification developeraccessdata.fda.gov
Transmitters And Receivers, Physiological Signal, RadiofrequencyDRG2Manufacturer, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 28, 2012K123020BLIP MODEL BP-700WFDXNSubstantially EquivalentCarematix, Inc.accessdata.fda.gov
May 5, 2010K100508CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-BDRGSubstantially EquivalentCarematix, Inc.accessdata.fda.gov
January 11, 2008K073038CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-BDRGSubstantially EquivalentCarematix, Inc.accessdata.fda.gov
June 2, 2004K040966MODIFICATION TO CAREMATIX WELLNESS SYSTEMDRGSubstantially EquivalentCarematix, Inc.accessdata.fda.gov
October 10, 2003K031840CAREMATIX WELLNESS SYSTEMDXNSubstantially EquivalentCarematix, Inc.accessdata.fda.gov

Compare with other makers

Updated November 28, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.