(108 days)
The Recovery Pump 737R is an air compression therapy device intended to provide graduated pressure to compression gaments. The Recovery Pump 737R 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 737R simulates kneading of tissues by using an inflatable garment.
The Recovery Pump 737R is an air compression therapy device intended to provide graduated pressure to compression gaments. The Recovery Pump 737R simulates kneading of tissues by using an inflatable garment.
The provided document is a 510(k) premarket notification decision letter for the MEGO AFEK AC Ltd. Recovery Pump 737R. It states that the device has been found substantially equivalent to legally marketed predicate devices.
However, the document does not contain specific information regarding:
- Acceptance criteria and reported device performance related to a study. The letter confirms the device's substantial equivalence but does not detail a study proving specific performance metrics against acceptance criteria.
- Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or details on ground truth for any reported study. This type of information is typically found in a detailed study report or clinical trial summary, which is not part of this 510(k) decision letter.
The document primarily focuses on the regulatory determination of substantial equivalence based on the provided indications for use: "The Recovery Pump 737R is an air compression therapy device intended to provide graduated pressure to compression garments. The Recovery Pump 737R 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 737R simulates kneading of tissues by using an inflatable garment."
Therefore, based only on the provided text:
No information regarding acceptance criteria or a study proving the device meets acceptance criteria is present in this document. The document is a regulatory approval letter based on substantial equivalence, not a detailed study report.
§ 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).