 | This article is rated Stub-class on Wikipedia's content assessment scale. |
FDA Approval
editI added the footnote for the January 2010 FDA approval. This device had a previous approval by the FDA in 2006 for a slightly different use. See http://www.accessdata.fda.gov/cdrh_docs/pdf6/K060439.pdf for more information on the 2006 approval. This information should be added to the article for completeness. Bear475 (talk) 14:21, 3 May 2010 (UTC)
Similar device
editThis device is similar to Acappela Choice marketed by Smiths Medical (http://www.smiths-medical.com/catalog/bronchial-hygiene/acapella-choice/acapella-choice.html). The Acapella device was the comparison device for the FDA testing procedure. Bear475 (talk) 14:56, 3 May 2010 (UTC)