Intouch Remote Presence Robotic System RP-7
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K073710 FDA 510(k)
- FDA Product Code
- DRG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2910 FDA 510(k)
- Regulation Number
- 870.2910 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Intouch Remote Presence Robotic System RP-7 is a mobile robotic platform designed for remote patient monitoring and clinical presence. It enables healthcare professionals to conduct real-time visual and auditory interactions with patients or colleagues from a remote location, facilitating telemedicine and remote consultation. The system integrates physiological signal transmitters and receivers using radiofrequency technology to support clinical assessments and interventions.
The RP-7 is supplied as a reusable, non-sterile device consisting of a mobile robot and a ControlStation (desktop or laptop computer). It operates within clinical settings, including hospitals and outpatient facilities, and is intended for use in environments compatible with wireless networks (e.g., 802.11). The system has been classified under Transmitters and Receivers, Physiological Signal, Radiofrequency (Device Class II) and holds an FDA 510(k) clearance (K073710) under regulation 870.2910. No MRI safety or sterility requirements are specified.
Frequently asked questions
What is the primary use of the Intouch Remote Presence Robotic System RP-7 in clinical settings?
The Intouch Remote Presence Robotic System RP-7 is designed for remote patient monitoring and clinical presence, allowing healthcare professionals to conduct real-time visual and auditory interactions with patients or colleagues from a remote location. This facilitates telemedicine and remote consultations in environments like hospitals and outpatient facilities that support wireless networks (e.g., 802.11).
Is the Intouch Remote Presence Robotic System RP-7 intended for single-use or reusable applications?
The RP-7 is explicitly described as a reusable device. It consists of a mobile robot and a ControlStation (desktop or laptop computer), and there are no indications or requirements for single-use or sterility, as it is classified as non-sterile.
How does the Intouch Remote Presence Robotic System RP-7 integrate with clinical workflows, particularly in terms of physiological monitoring?
The RP-7 integrates physiological signal transmitters and receivers using radiofrequency technology, enabling clinical assessments and interventions during remote interactions. This feature supports real-time monitoring and communication, making it suitable for environments where wireless networks are compatible.
What regulatory pathway was followed for the FDA clearance of the Intouch Remote Presence Robotic System RP-7?
The RP-7 received FDA clearance through a 510(k) submission, specifically under the traditional review pathway. It was classified as a Class II device under Transmitters and Receivers, Physiological Signal, Radiofrequency (Device Code: DRG), and holds clearance number K073710. The submission was reviewed by the Cardiovascular (CV) Advisory Committee.
Does the Intouch Remote Presence Robotic System RP-7 require any special storage conditions?
The device data does not specify any special storage conditions for the RP-7, such as temperature or environmental requirements. However, since it is reusable and operates in clinical settings, it should be stored in a clean, dry environment to maintain functionality and hygiene standards.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Intouch Remote Presence Robotic System, Model Rp-7 (K073710) — Fda 510 ..., INTOUCH REMOTE PRESENCE ROBOTIC SYSTEM, MODEL RP-7 510 (k) K073710 ..., Robot | RP-7 | Description | Robotics Today
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K073710 | Class II | Active |
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Manufacturer
- Manufacturer
- Intouch Technologies
Sources (1)
- FDA 510(k) K073710 24 fields · synced Sep 20, 2026