(106 days)
- Primary lymphedema .
- Secondary lymphedema .
- . Venous insufficiency
- Venous stasis ulcers .
- Dysfunction of the muscle pump .
Not Found
The provided document is a 510(k) clearance letter from the FDA for a medical device called "Practical Compression Device (PCD) 901A and 901B." This type of document confirms that the FDA has found the device to be "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective as existing devices.
Crucially, this document is a regulatory clearance letter and does not contain information about acceptance criteria or the specifics of a study proving the device meets acceptance criteria.
The FDA 510(k) process primarily relies on demonstrating substantial equivalence to a predicate device, which often involves comparing technical characteristics, materials, and intended use, rather than extensive clinical efficacy studies with predefined acceptance criteria and performance metrics described in such detail.
Therefore, I cannot extract the requested information from this document. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical study report submitted to the FDA as part of a premarket approval (PMA) application or a de novo classification request, or even a detailed 510(k) submission summary that voluntarily includes such study details.
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).