← Product Code [HCC](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC) · K020399 # RESPERATE; MODEL RR-150 (K020399) _Intercure , Ltd. · HCC · Jul 2, 2002 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC/K020399 ## Device Facts - **Applicant:** Intercure , Ltd. - **Product Code:** [HCC](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC.md) - **Decision Date:** Jul 2, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.5050 - **Device Class:** Class 2 - **Review Panel:** Neurology - **Attributes:** Therapeutic ## Indications for Use The RESPeRATE is intended for use as a relaxation treatment for the reduction of stress by leading the user through interactively guided and monitored breathing exercises. The device is indicated for use only as an adjunctive treatment for high blood pressure, together with other pharmacological and/or non-pharmacological interventions. ## Device Story RESPeRATE is a biofeedback device for stress reduction and blood pressure management. It monitors user breathing patterns and provides interactive guidance to regulate respiration. Used in home settings by patients without physician supervision. Device guides users through breathing exercises; output helps patients achieve relaxation; intended to provide clinically significant blood pressure reduction as an adjunct to other therapies. ## Clinical Evidence Clinical study conducted in an OTC setting over 8 weeks. Results demonstrated a safe, clinically significant reduction in high blood pressure in patients using the device without physician guidance. ## Technological Characteristics Biofeedback device; operates on the same principles as the predicate Respi-Low. Features interactive breathing guidance and monitoring. No specific materials or software architecture details provided. ## Regulatory Identification A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9. ## Predicate Devices - Respi-Low Model RL-108 ([K000495](/device/K000495.md)) ## 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}------------------------------------------------ 020399 1/2 ## ATTACHMENT 9 # 510(k) Summary For The InterCure Ltd. RESPeRATE ### Submitter's Name, Address, Telephone Number, and Contact Person ﺴﺮ InterCure Ltd. 9 Hamelacha st. Kislev building Northern Industrial area, Lod, 71520 Israel | Contact: | Dr. Benjamin Gavish
Chief Scientist, InterCure Ltd | |------------|-------------------------------------------------------| | Phone: | 972-8-9212126 | | Facsimile: | 972-8-9204001 | | Email: | bgavish@intercure.com | #### Date Prepared: January 2002 #### Name of the Device #### RESPeRATE #### Common or Usual Name Biofeedback Device #### Predicate Device Respi-Low Model RL-108 (K000495) manufactured by InterCure Ltd .; #### Intended Use The RESPeRATE is intended for use as a relaxation treatment for the reduction of stress by leading the user through interactively guided and monitored breathing exercises. The device is indicated for use only as an adjunctive treatment for high blood pressure, together with other pharmacological and/or non-pharmacological interventions. {1}------------------------------------------------ ## Summary of the Basis for the Finding of Substantial Equivalence The RESPeRATE is substantially equivalent to InterCure's previously cleared Respi-Low biofeedback device (K000495) for use in stress reduction and adjunctive treatment to reduce blood pressure. The device shares the same general intended use in relaxation and/or stress reduction and the same indications for use except for OTC use. Moreover, the principles of operation are identical to the predicate device and there are only minor differences in technological characteristics. Clinical testing in the OTC setting has shown that the RESPeRATE device can be properly used without the direction of a physician. This difference in the specific indications for use of the RESPeRATE (for OTC use) compared to the predicate (for prescription use), however, does not raise new questions of safety or efficacy and does not alter its therapeutic effect. Moreover, the clinical study demonstrated a safe, clinically significant, reduction in high blood pressure with use of the RESPeRATE over a period of 8 weeks without the guidance of a physician. Therefore, the devices are substantially equivalent. 2 2/2 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized representation of a human figure with three profiles overlapping each other. The profiles are arranged in a way that creates a sense of depth and continuity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the figure. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL = 2 2002 InterCure LTD. c/o Jonathan S. Kahan Hogan and Hartson, L.L.P. 555 13th Street, N.W. Washington, D.C. 20004-1109 Re: K020399 Trade Name: RESPeRATE Regulation Number: 882.5050 Regulation Name: Biofeedback device Regulatory Class: II Product Code: HCC Dated: May 9, 2002 Received: May 9, 2002 Dear Mr. Kahan: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. 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. {3}------------------------------------------------ Page 2 -- Mr. Jonathan S. Kahan 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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). 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, Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(k) Number (if known):_ K 020 399 Device Name: InterCure Ltd. RESPeRATE Indications for Use: The RESPeRATE is intended for use as a relaxation treatment for the reduction of stress by leading the user through interactively guided and monitored breathing exercises. The device is indicated for use only as an adjunctive treatment for high blood pressure, together with other pharmacological and/or non-pharmacological interventions. (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use *X* (Per 21 C.F.R. 801.109) (Optional Format 1-2-96) Hyatt Murda (Division Sign-Off) Division of General, Restorative and Neurological Devices KOZO3999 510(k) Number_ --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC/K020399](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC/K020399) **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