(85 days)
The Boehringer Laboratories, Inc. Pneumatic Ambulatory Compression System (PACS™) is indicated for the application of controlled pressure to the lower extremities in order to prevent blood pooling in the lower venous leg. Pooling of blood in the legs is associated with: venous insufficiency, edema, lymphedema, active venous ulcers, healed venous ulcers, pronounced varicosities and post-thrombotic syndrome. The PACS™ is to be used on the order of a Physician.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the Boehringer Laboratories Pneumatic Ambulatory Compression System (PACS). This document primarily focuses on establishing substantial equivalence to a predicate device and regulatory compliance.
It DOES NOT contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
Therefore, I cannot provide the requested table and details based on the given input. The document is strictly a regulatory clearance and does not include the technical performance data that would typically be found in a study report.
§ 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.