← Product Code [DQD](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD) · K032230 # RHYTHM DIGITAL ELECTRONIC STETHOSCOPE (K032230) _Thinklabs, Inc. · DQD · Nov 26, 2003 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD/K032230 ## Device Facts - **Applicant:** Thinklabs, Inc. - **Product Code:** [DQD](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD.md) - **Decision Date:** Nov 26, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1875 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for Use The "Rhythm Digital Electronic Stethoscope" is intended for use as a diagnostic aid in patient diagnosis. It can be used for the amplification of heart, lung, and other body sounds with selective frequency filtering and can be used on any patient undergoing physical assessment. The device can also be used to measure heart rate, based on measurement of heart sound signals. ## Device Story The Rhythm Digital Electronic Stethoscope is a diagnostic aid used by clinicians during physical examinations. It captures acoustic body sounds (heart, lung, and other body sounds) via a sensor, amplifies these signals, and applies selective frequency filtering to enhance auscultation. The device also processes heart sound signals to calculate and display heart rate. It functions as an electronic stethoscope, providing clinicians with improved sound clarity and objective heart rate data to assist in patient diagnosis. The device is intended for use in clinical settings where traditional stethoscopes are employed. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Electronic stethoscope; utilizes acoustic sensors for sound capture; includes signal amplification and frequency filtering circuitry; provides heart rate measurement based on acoustic signal processing; handheld form factor. ## Regulatory Identification Manual stethoscope: A mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. Electronic stethoscope: An electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs. ## Special Controls *Classification.* Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. ## 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}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wavy lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 26 2003 Thinklabs, Inc. c/o Mr. Richard C. Lanzillotto Authorized Agent NATS Corp. 30 Northport Rd. Sound Beach, NY 11789 Re: K032230 Trade Name: Rhythm Digital Electronic Stethoscope Regulation Number: 21 CFR §870.1875 Regulation Name: Electronic Stethoscope Regulatory Class: Class II (two) Product Code: DQD Dated: October 28, 2003 Received: October 30, 2003 Dear Mr. Lanzillotto: 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. Richard C. Lanzillotto 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 (OS) 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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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, Tomá Reischer for Bram D. Zuckerman, M.D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Thinklabs Inc. Rhythm Digital Electronic Stethoscope 510K Notification ## INDICATIONS FOR USE 510(k) Number (if known): Thinklabs Inc. "Rhythm Digital Electronic Stethoscope" Device Name: The "Rhythm Digital Electronic Stethoscope" is intended for use as a Indications for Use: diagnostic aid in patient diagnosis. It can be used for the amplification of heart, lung, and other body sounds with selective frequency filtering and can be used on any patient undergoing physical assessment. The device can also be used to measure heart rate, based on measurement of heart sound signals. (Please do not write below this line-continue on another Page if needed) ________________________________________ Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use Dwa Seexluu 510(k) Number K032230 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD/K032230](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD/K032230) **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. 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