(605 days)
The Walkcare P200 system is indicated for improved blood circulation, prevention of deep vein thrombosis and reduces pain, chronic and acute edema, leg ulcers, compartmental pressure, venous stasis and complications of poor circulation, in the lower extremeties.
WalkCare P200 - A foot compression system
This document is a 510(k) clearance letter for the WalkCare P200 System, a foot compression system. This type of document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed studies on acceptance criteria and device performance as would be found in a clinical study report or a premarket approval (PMA) application.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information is not available within the provided text.
The letter indicates that the FDA has reviewed the 510(k) notification and determined the device is "substantially equivalent" to legally marketed predicate devices for the stated indications for use (improved blood circulation, prevention of deep vein thrombosis, and reduction of pain, chronic and acute edema, leg ulcers, compartmental pressure, venous stasis, and complications of poor circulation in the lower extremities).
To obtain the detailed information requested, one would typically need to consult the full 510(k) submission, which is not provided here.
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).