Medical DeviceMay 6, 2015
Therasage, LLC FAR-Infrared Heat Home Sauna, 3 person Indications including, but not limited recall — FDA Z-1540-2015
Product distributed without 510(k) approval
Class IIFDA: TerminatedTherasage, LLC.
Recall history in this database
Classification mix: Class II: 3.
Medical DeviceMay 6, 2015
Therasage, LLC Portable FAR Infrared Sauna Indications including, but not limited to Natural recall — FDA Z-1541-2015
Product distributed without 510(k) approval
Class IIFDA: TerminatedTherasage, LLC.
Medical DeviceMay 6, 2015
Therasage, LLC FAR-Infrared Heat Home Sauna, 2 person Indications including, but not limited recall — FDA Z-1539-2015
Product distributed without 510(k) approval
Class IIFDA: TerminatedTherasage, LLC.
Understanding this recall history
This page summarizes recall records in which the official source identifies Therasage, LLC. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.