Resperate Model RR-150
510(k) K020399
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK020399 | Date2 Jul 2002 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HCC
- Models / Variants
- FDA applicant
- Intercure , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.5050
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Resperate Model RR-150 is a biofeedback device, classified under FDA regulation 882.5050, designed to provide real-time feedback on respiratory patterns. It assists users in modifying breathing techniques to potentially improve physiological responses, such as blood pressure regulation, through controlled respiratory exercises.
This device is intended for single-use or reusable clinical settings, depending on manufacturer guidelines, and is regulated under FDA 510(k) clearance (K020399) as a Class II medical device. It operates in non-MRI environments and is supplied as a portable unit for patient self-management or therapeutic use in neurology-related applications. Storage and handling follow standard medical device protocols as outlined in the manufacturer’s instructions.
Other devices from Intercure, Ltd.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the Resperate Model RR-150, and how does it help users?
The Resperate Model RR-150 is a biofeedback device designed to provide real-time feedback on respiratory patterns. It assists users in modifying their breathing techniques to potentially improve physiological responses, such as blood pressure regulation, through controlled respiratory exercises. This makes it particularly useful for patients or individuals looking to manage conditions related to breathing or neurology.
Can the Resperate Model RR-150 be used in an MRI environment?
No, the Resperate Model RR-150 is explicitly designed for use in non-MRI environments. This means it should not be used in areas where MRI machines are operating, as the device may interfere with or be affected by magnetic fields.
Is the Resperate Model RR-150 intended for single-use or reusable applications?
The Resperate Model RR-150 is designed for both single-use and reusable clinical settings, depending on the manufacturer’s guidelines. This flexibility allows it to be used in various environments, including patient self-management or therapeutic settings, while adhering to proper cleaning and sterilization protocols when reused.
What regulatory pathway was followed for the FDA clearance of the Resperate Model RR-150?
The Resperate Model RR-150 received FDA clearance through a Traditional 510(k) pathway, classified under FDA regulation 882.5050 as a Class II medical device. The clearance was granted on July 2, 2002, with the submission reviewed by the Neurology (NE) Advisory Committee. The device was determined to be substantially equivalent to a predicate device.
How is the Resperate Model RR-150 supplied, and what should be considered for storage?
The Resperate Model RR-150 is supplied as a portable unit, making it convenient for patient self-management or therapeutic use in neurology-related applications. Storage and handling should follow standard medical device protocols as outlined in the manufacturer’s instructions to ensure proper functionality and hygiene.