(76 days)
The Recovery Pump is an air compression therapy device intended to provide graduated pressure to compression garments. The Recovery Pump is indicated for the temporary relief of minor muscle aches and pains, and for temporary increase in blood circulation to the treated areas in people who are in good health. The Recovery Pump simulates kneading and stroking of tissues by using an inflatable garment.
The Recovery Pump is an air compression therapy device intended to provide graduated pressure to compression garments.
The provided text is a 510(k) clearance letter from the FDA for a device called "Recovery Pump, 737R (RPX)." This document explicitly states the regulatory clearance of the device based on substantial equivalence to legally marketed predicate devices.
However, this document does NOT contain information about specific acceptance criteria for a study proving device performance, nor does it describe a study itself.
The letter focuses on:
- Confirming the device's substantial equivalence to predicate devices.
- Stating the intended use/indications for use (found in the enclosure).
- Outlining the general regulatory controls the device must comply with.
Therefore, I cannot extract the requested information from the provided text as it does not contain a description of a performance study with acceptance criteria.
To answer your request, a document detailing device performance testing, such as a summary of safety and effectiveness, clinical study report, or test report, would be required.
§ 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).