(48 days)
Compression Class I Mild swelling, tired aching legs, thrombosis prophylaxis, minor varices, post surgery
Compression Class II Primary varices, varices with edema, varices with pregnancy; post-sclerotherapy; post venous ulceration
Compression class III Secondary varices; severe varices with edema; post-phlebitic syndrome; chronic venous insufficiency; phiebitis; thrombophlebitis and edema
Not Found
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical support stocking (Bellavar, Custom Seamless Soft). It confirms the device's substantial equivalence to a predicate device and lists its indications for use.
However, the letter does not include any details about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any comparative effectiveness studies. These types of details are typically found in the 510(k) submission itself or in separate study reports, not in the clearance letter from the FDA.
§ 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.