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510(k) Data Aggregation
(254 days)
To apply compression to the lower limbs to help prevent deep vein thrombosis in patients at risk.
MRSI Compressible Limb Sleeve
This document is a 510(k) clearance letter from the FDA for a medical device called the "MRSI Compressible Limb Sleeve." It primarily addresses the regulatory approval of the device and does not contain information about specific acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot fulfill your request for the detailed information as described in your prompt from the provided text. The document focuses on regulatory equivalence to a predicate device rather than performance metrics from a specific study.
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