(111 days)
8-15 mmHg Mild For tired, aching legs, minor leg swelling, leg pain, poor blood circulation 8
10-20 mmHg Anti-Embolism Stocking - Helps prevent edema and leg discomfort, and helps prevent deep vein thrombosis (DVT) in patients subjected to immobility.
15-20 mmHg Moderate Firm - For mild varicose veins, post surgery, poor blood circulation, leg discomfort, mild to moderate swelling, tired and aching legs - Helps prevent deep vein thrombosis for long distance travelers and edema
20-30 mmHg - For varicose veins, post surgery, venous insufficiency, moderate to severe varicosis, moderate swelling - Helps prevent deep vein thrombosis for long distance travelers and edema
30-40 mmHg Extra Firm - For edema, after healing of leg ulcers, severe chronic venous insufficiency, postphlebitic syndrome, post deep vein thrombosis (DVT), advanced varicose veins, phlebitis and reversible lymphedema - Post varicose vein surgery, vein stripping, sclerotherapy, plebectomy
Not Found
This document is a 510(k) clearance letter for "Bossong Hosiery Medical Support Stockings." It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain information on acceptance criteria, a study proving device performance against those criteria, or any of the detailed study parameters requested (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance). The letter is a regulatory approval document and not a scientific study report.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about a study that proves the device meets those criteria, as this information is not present in the provided document.
§ 880.5780 Medical support stocking.
(a)
Medical support stocking to prevent the pooling of blood in the legs —(1)Identification. A medical support stocking to prevent the pooling of blood in the legs is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for use in the prevention of pooling of blood in the leg.(2)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.(b)
Medical support stocking for general medical purposes —(1)Identification. A medical support stocking for general medical purposes is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for medical purposes other than the prevention of pooling of blood in the leg.(2)
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.