← Product Code [DXH](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH) · K023689 # CG-500 PMP PERSONAL MEDICAL PHONE SYSTEM (K023689) _Card Guard Scientific Survival , Ltd. · DXH · Jan 17, 2003 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K023689 ## Device Facts - **Applicant:** Card Guard Scientific Survival , Ltd. - **Product Code:** [DXH](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH.md) - **Decision Date:** Jan 17, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.2920 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for Use The CG-500 PMP4 portable Personal Medical Phone System is intended for: a) Patients wishing to acquire, display and transmit their vital signs to a medical professional via Web-based Call Center for analysis and obtain response b) Physicians for medical testing of patients' vital signs, display and analysis as well as follow up and response to patient's transmitted data ## Device Story CG-500 PMP4 is a portable system for vital sign acquisition, display, and transmission. Patients use the device to capture vital signs and transmit them via a Web-based Call Center; physicians receive, analyze, and respond to the data. The system facilitates remote medical testing and patient follow-up. It serves as a communication link between patient and clinician, enabling remote monitoring and clinical decision-making based on transmitted physiological data. ## Clinical Evidence No clinical data provided; substantial equivalence determination based on device description and intended use. ## Technological Characteristics Portable system for vital sign acquisition and transmission. Connectivity via Web-based Call Center. Class II device, product code DXH. ## Regulatory Identification A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Public Health Service Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name arranged in a circular pattern around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## JAN 1 7 2003 Card Guard Scientific Survival Ltd. c/o Mr. Alex Gonorovsky Regulatory Affairs, QA 2 Pekeris St., P.O. Box 527 Rehovot 76101 Israel Re: K023689 Trade Name: CG-500 PMP4 Personal Medical Phone System Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DXH Dated: September 15, 2002 Received: November 1, 2002 Dear Mr. Gonorovsky: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ ## Page 2 - Mr. Alex Gonorovsky Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product 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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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, V. Walter Tull Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Image /page/2/Figure/0 description: The image shows the logo for Card Guard Scientific Survival LTD. The logo is in black and white and features the words "CARD GUARD" in bold letters above the words "Scientific Survival LTD." There is a line above the words "Scientific Survival LTD." To the right of the words is a line that resembles an EKG. 510(k) Number (if known): The CG-500 PMP4 portable Personal Medical Phone System is intended for: Patients wishing to acquire, display and transmit their vital signs to a medical a) professional via Web-based Call Center for analysis and obtain response b) Physicians for medical testing of patients' vital signs, display and analysis as well as follow up and response to patient's transmitted data PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use ✔ OR (Per 21 CFR 801.109) (Optional Format 1-2-96) Over-The-Counter Use 17 N. Dege Tu 510(k) Numbe --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K023689](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K023689) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com