(260 days)
Air Pressure Therapy System (Model:VU-IPC4M) is intended for home to temporarily relieve minor muscle aches and or pains, and to temporarily increase circulation to the treated areas in people who are in good health.
Air Pressure Therapy System (Model:VU-IPC4M) consists of air pressure sensor, air pump, sleeves Etc. working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses. The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor.
The provided document is an FDA 510(k) clearance letter for the Xiamen Weiyou Intelligent Technology Co., Ltd. Air Pressure Therapy System (Model: VU-IPC4M). This letter declares the device substantially equivalent to legally marketed predicate devices.
Crucially, this document is a regulatory clearance and not a detailed study report or clinical trial result. It does not contain information about the specific acceptance criteria for an AI/ML device's performance, nor does it present the results of a study designed to prove the device meets such criteria in terms of diagnostic accuracy or clinical effectiveness.
The "Performance Testing - Clinical" and "Performance Testing - Animal" sections explicitly state "Not Applicable," indicating that the manufacturer did not submit clinical or animal study data to support this 510(k) submission. Therefore, it is impossible to extract the requested information (acceptance criteria, device performance, sample size, ground truth establishment, expert adjudication, MRMC studies, standalone performance) for an AI/ML component from this document.
The document focuses on non-clinical performance testing related to the physical device itself and its electrical safety, biocompatibility, and mechanical integrity, as summarized under "Performance Characteristic."
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding the study design elements (sample size, data provenance, expert adjudication, MRMC, standalone performance, ground truth) as they are directly linked to performance evaluation against clinical or diagnostic endpoints, which are not detailed in this regulatory submission.
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).