Why replace the pad on its labeled expiration date?
We have conducted extensive safety and efficacy testing to support a product life of 18 months. We have no data to support the use of the pad beyond this time. At the time of expiration, the product indemnity against claims by patients does expire. The FDA requires medical device manufacturers to have a means for identifying a reusable product’s end-of-life. Based on the product design and our safety and efficacy testing we have chosen to place an expiration date on the pad to identify its end-of-life. The FDA reviewed our 510(k) submission with this information and has allowed us to market the product.
