Search Results

The UMED REPROCESSED CTC VP 520 FOOT CUFF is used in the same manner as intended by the original device manufacturer (OEM) to increase venous blood flow in patients at risk of developing Deep Vein Thrombosis (DVT) and pulmonary embolism (PE). The device is a prescription device for the use in a clinical setting or in the home.

The UMED REPROCESSED CTC VP 501 CALF CUFF is used in the same manner as intended by the original device manufacturer (OEM) to increase venous blood flow in patients at risk of developing Deep Vein Thrombosis (DVT) and pulmonary embolism (PE). The device is a prescription device for the use in a clinical setting or in the home.

The UMED REPROCESSED AIRCAST ELITE CALF CUFF 3040 / 3050 is used in the same manner as intended by the original device manufacturer (OEM) to increase venous blood flow in at-risk patients in order to prevent deep vein thrombosis (DVT) and. The device is a prescription device for the use in a clinical setting or in the home.

The UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE is used in the same manner as intended by the original device manufacturer (OEM) to increase venous blood flow in patients at risk of developing Deep Vein Thrombosis (DVT) and pulmonary embolism (PE). The device is a prescription device for the use in a clinical setting or in the home.

The UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF is used in the same manner as intended by the original device manufacturer (OEM) to increase venous blood flow in at- risk patients in order to prevent deep vein thrombosis (DVT). The device is a prescription device for the use in a clinical setting or in the home.

Not Found

The provided document is an FDA 510(k) clearance letter for reprocessed medical devices, specifically compressible limb sleeves used to prevent Deep Vein Thrombosis (DVT) and pulmonary embolism (PE).

It is important to note that this document DOES NOT contain information about acceptance criteria or a study proving that a device meets such criteria. The letter is a regulatory approval, stating that the reprocessed devices are substantially equivalent to legally marketed predicate devices. It discusses general controls, regulations, and reporting requirements, but not the specific performance testing data, acceptance criteria, or study methodologies that would be used to demonstrate a device's performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided input. The document does not contain the information required to populate the table or answer the other questions about study design, ground truth, or expert involvement.

Ask a specific question about this device