CAREMATIX INC.

FDA Device Registration & Listing · CHICAGO, IL, US · Registration 3003982635

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003982635
FEI Number
3003982635
Entity Name
CAREMATIX INC.
City/State/Country
CHICAGO, IL, US
Establishment Address
1 N LaSalle St Suite 4400, CHICAGO, IL 60602, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
CAREMATIX INC. (Owner Number: 9053352)
Owner / Operator Contact Address
1 N LaSalle St Suite 4400, Chicago, IL 60602, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K031840
PMA Number
N/A

All Registered Proprietary Names

Carematix Wellness System Blip WiFi Weight Scale WS5500-WF Carematix Wellness System Carematix Wellness System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency Cardiovascular Class 2 870.2910 2008-03-11
FRI Scale, Stand-On, Patient General Hospital Class 1 880.2700 2015-05-21
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency Cardiovascular Class 2 870.2910 2008-03-11
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2012-12-06
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency Cardiovascular Class 2 870.2910 2012-12-06
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2008-03-11
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency Cardiovascular Class 2 870.2910 2008-03-11

Official Correspondent

SUKHWANT KHANUJA

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CAREMATIX INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K131913 Philips Medizin Systeme Boeblingen GmbH INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC 2013-11-26
K100940 Andon Health Co, Ltd. FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 2010-06-29
K251581 Shenzhen Hingmed Medical Instrument Co., Ltd. Wearable Ambulatory Blood Pressure Monitor (WBP-02A) 2026-02-13
K200521 Health & Life Co., Ltd. Full Automatic(NIBP) Blood Pressure Monitor 2020-06-12
K152003 Andon Health Co, Ltd. iHealth BP3L Wireless Blood Pressure Monitor 2015-09-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0032-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003982635. Last updated year: 2026. Please use registration number 3003982635 when referencing this establishment in official correspondence.
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