(114 days)
The air compression leg massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The air compression leg massager simulates kneading and stroking of tissues by using an inflatable garment.
Not Found
This document is an FDA clearance letter for a medical device called an "Air compression leg massager" (K240981).
Based on the provided text, the document does not contain information about acceptance criteria or supporting studies related to device performance.
The letter from the FDA confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls of the Act. It outlines regulatory requirements, such as annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. It also mentions other applicable regulations like the Quality System (QS) regulation.
Therefore, I cannot provide the requested information about acceptance criteria and study details because it is not present in the provided FDA clearance letter.
The letter focuses on the regulatory clearance process, not on the specific performance data or study results of the device.
§ 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).