(108 days)
Not Found
No
The document describes a standard blood pressure monitor with no mention of AI or ML capabilities, image processing, or data sets for training/testing.
No
The device is a blood pressure monitor used for measurement and monitoring, not for treating a condition or disease.
No
A diagnostic device is used to identify or determine the nature of a disease or condition. This device measures blood pressure and pulse rate, which are vital signs, but it does not inherently diagnose a condition. While the measurements it provides can inform a diagnosis made by a healthcare professional, the device itself is for monitoring, not diagnosis.
No
The device description explicitly lists hardware components such as an inflatable cuff, LCD display, semiconductor sensor, internal air pump, battery power source, and keys for operation. This indicates it is a hardware device with potentially embedded software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Zewa® MFM-007 Blood Pressure Monitor measures blood pressure and pulse rate directly from the body using a cuff on the upper arm. It does not analyze specimens taken from the body.
Therefore, based on the provided information, the Zewa® MFM-007 Blood Pressure Monitor is a non-invasive medical device for measuring physiological parameters, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Zewa MFM-007 Blood Pressure Monitor is intended for use by adults with moderately active to inactive lifestyles for measuring the systolic and diastolic blood pressure, and pulse rate (heart rate) by using an inflated cuff which is wrapped around the upper arm.
Product codes
DXN
Device Description
The Zewa® MFM-007 Blood Pressure Monitor measures the systolic and diastolic blood pressure, and pulse rate (heart rate) by use of an inflatable cuff that is wrapped around the upper arm, a LCD display, a semiconductor sensor, and internal air pump, a battery power source and keys for operation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
adults
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The Zewa® MFM-007 Blood Pressure Monitor was tested for compliance with numerous technical specifications, including general performance under certain environmental conditions, influences of static electrical discharges, influences of irradiated electromagnetic field, and radio screening.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
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510(K) SUMMARY SECTION 16
1. DATE PREPARED
June 2, 2004
2. SPONSOR INFORMATION
Zewa Inc. Mr. Thomas Zeindler 3537 N.W. 115th Avenue Miami, Florida 33178
(305) 463-7551 (telephone) (305) 463-7553 (facsimile)
3. DEVICE NAME
Proprietary Name: Zewa® MFM-007 Blood Pressure Monitor Common/Usual Name: MFM-007 Blood Pressure Monitor Classification Name: System, Measurement, Blood Pressure, Non Invasive
4. DEVICE DESCRIPTION AND INTENDED USE
The Zewa® MFM-007 Blood Pressure Monitor is intended for use by adults with moderately active to inactive lifestyles for measuring the systolic and diastolic blood pressure, and pulse rate (heart rate) by using an inflated cuff which is wrapped around the upper arm.
PREDICATE DEVICE న్.
It is substantially equivalent to the Meditec MD-800 Noninvasive Blood Pressure Measurement System cleared by FDA on July 21, 1999, under 510(k) K992328.
TECHNOLOGICAL CHARACTERISTICS 6.
The Zewa® MFM-007 Blood Pressure Monitor measures the systolic and
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diastolic blood pressure, and pulse rate (heart rate) by use of an inflatable cuff that is wrapped around the upper arm, a LCD display, a semiconductor sensor, and internal air pump, a battery power source and keys for operation.
DEVICE TESTING 7.
The Zewa® MFM-007 Blood Pressure Monitor was tested for compliance with numerous technical specifications, including general performance under certain environmental conditions, influences of static electrical discharges, influences of irradiated electromagnetic field, and radio screening.
2
Public Health Service
Image /page/2/Picture/2 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the border. Inside the circle is a stylized image of an eagle with three stripes across its body. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 0 2004
Zewa, Inc. c/o Mr. Thomas Zeindler Vice President 3537 N.W. 115th Avenue Miami, FL 33178
Re: K041491
. Trade/Device Name: Zewa MFM-007 Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive blood pressure measurement system Regulatory Class: II (two) Product Code: DXN Dated: June 2, 2004 Received: June 4, 2004
Dear Mr. Zeindler:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your bectoril 310(x) presidentially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the cherosure) to regars nement date of the Medical Device Americal Ford. Days commerce prior to May 20, 1978, the excordance with the provisions of the Federal Food. Drug. devices that have been reclassined in asses approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require subject to the general controls provisions of the Act. The 1 ou may, dicierore, market the device, poolee requirements for annual registration, listing of general controls provisions of the flev labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (see abort) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations on may be subject to such additional consolors, Title 21, Parts 800 to 898. In addition, FDA may oc found in the Oous cements concerning your device in the Federal Register.
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Page 2 – Mr. Thomas Zeindler
Please be advised that FDA's issuance of a substantial equivalence determination are not mean Please be advised that FDA s issuation of a buobained with other requirements of the Act
that FDA has made a determination that your device complies with other requirements o that FDA has made a determination that your are for a level Federal agencies. You must or any Federal Statutes and regulations damading, but not limited to: registration and listing (21 l comply with an the Act 3 requirements, mercess comments on the practice requirements as set CFK Part 807), labeling (21 CFR Part 800), good if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Doctors of 1 vice as described in your Section 5 10(k)
This letter will allow you to begin marketing your device as described in your be I his letter will anow you to begin maileting your antial equivalence of your device to a legally premitset notification. The PDA miang of basification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your de 110 - 110 - 4648. Also, please note the regulation entitled,
contact the Office of Compliance at (301) 594-4648. Also, please note Colliact the Office of Compunation at (50 m ) (21CFR Part 807.97). You may obtain " Misorationing by reletence to premanton notifications in the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Dffimmuma for
Brain D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K041491
Device Name: Zewa MFM-007 Blood Pressure Monitor
Indications For Use:
The Zewa MFM-007 Blood Pressure Monitor is intended for use by adults with moderately active to inactive lifestyles for measuring the systolic and diastolic blood moderately active to machie in ste) by using an inflated cuff which is wrapped around the upper arm.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bhimma for
(Division Sign Off)
Division of Cardiovascular Devices
510(k) Number K041491
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