SEP tO 2 004 K o LqSECTION 16 510K SUMMARY1 DATE PREPAREDJune - PDF document

1 SEP tO 2 004 K/ o-/ L)q/SECTION 16 510(K
SEP tO 2 004 K/ o-/ L)q/SECTION 16 510(K) SUMMARY1. DATE PREPAREDJune 2, 20042. SPONSOR INFORMATIONZewa Inc.Mr. Thomas Zeindler3537 N.W. 115thAvenueMiami, Florida 33178(305) 463-7551 (telephone)(305) 463-7553 (facsimile)3. DEVICE NAMEProprietary Name: Zewa® MFM-007 Blood Pressure MonitorCommon/Usual Name: MFM-007 Blood Pressure MonitorClassification Name: System, Measurement, Blood Pressure, NonInvasive4. DEVICE DESCRIPTION AND INTENDED USEThe Zewa® MFM-007 Blood Pressure Monitor is intended for use by adults withmoderately active to inactive lifestyles for measuring the systolic and diastolicblood pressure, and pulse rate (heart rate) by using an inflated cuff which iswrapped around the upper arm.5. PREDICATE DEVICEIt is substantially equivalent to the Meditec MD-800 Noninvasive Blood PressureMeasurement System cleared by FDA on July 21, 1999, under 5 10(k) K992328.6. TECHNOLOGICAL CHARACTERISTICSThe Zewa® MFM-007 Blood Pressure Monitor measures the systolic and-10-5 10(K) Application 2004 diastolic blood pressure, and pulse rate (heart rate) by use of an inflatable cuff thatis wrapped around the upper a

2 rm, a LCD display, a semiconductor senso
rm, a LCD display, a semiconductor sensor, andinternal air pump, a battery power source and keys for operation.7. DEVICE TESTINGThe Zewa® MFM-007 Blood Pressure Monitor was tested forcompliance with numerous technical specifications, including generalperformance under certain environmental conditions, influences of static electricaldischarges, influences of irradiated electromagnetic field, and radio screening.-11-5 10(K) Application 2004 DEPA.RTMENT OF -HEALTH & HUMAN SERVICES Public Health ServiceFood and Drug Administration9200 Corporate BoulevardRockvilie MD 20850SEP 2 0 2004Zewa, Inc.c/o Mr. Thomas ZeindlerVice President3537 N.W. 115th AvenueMiami, FL 33178Re: K041491Trade/Device Name: Zewa MFM-007 Blood Pressure MonitorRegulation Number: 21 CFR 870.1130Regulation Name: Non-invasive blood pressure measurement systemRegulatory Class: II (two)Product Code: DXNDated: June 2, 2004Received: June 4, 2004Dear Mr. Zeindler:We have reviewed your Section 510(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfo

3 r use stated in the enclosure) to legall
r use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices that have been reclassified in accordance with the provisions of the Federal Food, Drug,and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).You may, therefore, market the device, subject to the general controls provisions of the Act. Thegeneral controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration.If your device is classified (see above) into either class II (Special Controls) or class III (PMA), itmay be subject to such additional controls. Existing major regulations affecting your device canbe found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA maypublish further announcements concerning your device in the Federal Register. Page 2 -Mr. Thomas ZeindlerPlease be advised that FDA's issuance of a substantial equiva

4 lence determination does not meanthat FD
lence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act's requirements, including, but not limited to: registration and listing (21CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as setforth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronicproduct radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.This letter will allow you to begin marketing your device as described in your Section 5 10(k)premarket notification. The FDA finding of substantial equivalence of your device to a legallymarketed predicate device results in a classification for your device and thus, permits your deviceto proceed to the market.If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleasecontact the Office of Compliance at (301) 594-4648. Also, please note the regulation entitled,"Misbranding by reference to pre

5 market notification" (21CFRPart 807.97).
market notification" (21CFRPart 807.97). You may obtainother general information on your responsibilities under the Act from the Division of SmallManufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or(301) 443-6597 or at its Internet address hain.htmlSincerely yours,/Br/K D an, MDDirectorDivision of Cardiovascular DevicesOffice of Device EvaluationCenter for Devices andRadiological HealthEnclosure Indications for Use510(k) Number (if known): K041491Device Name: Zewa MFM-007 Blood Pressure MonitorIndications For Use:The Zewa MFM-007 Blood Pressure Monitor is intended for use by adults withmoderately active to inactive lifestyles for measuring the systolic and diastolic bloodpressure, and pulse rate (heart rate) by using an inflated cuff which is wrapped aroundthe upper arm.Prescription Use AND/OR Over-The-Counter Use _X(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)Concurrence of CDRH, Office of Device Evaluation (ODE)(Diin Sion-OfDivision of Cardiovascular Devices510(k) Number 0'4-/y/Page 1 of