Search Results

Medline ReNewal Reprocessed Compression Limb Sleeves are designed to be used with a pump system to apply sequential compression to the lower limbs to prevent deep vein thrombosis.

Medline ReNewal Reprocessed Compression Limb Sleeves are used with a pump system to apply sequential compression to the lower limbs (leg and foot). They are made of a variety of materials and come in various sizes. They are originally manufactured as single use devices.

I am sorry, but the provided text is a 510(k) summary for a medical device and does not contain the detailed information required to describe the acceptance criteria and the comprehensive study that proves the device meets those criteria. The document explicitly states:

• "The functional characteristics of the proposed devices have been evaluated and found to be equivalent to the predicate devices after the specified number of reprocessing cycles."
• "Testing included: bioburden testing; biocompatibility testing (cytotoxicity, irritation, sensitization); cleaning process validation; equipment qualification; and visual inspection."

While these are types of tests performed, the document does not provide:

1. A table of acceptance criteria and reported device performance: It lists types of tests but not specific criteria (e.g., "bioburden must be

Ask a specific question about this device