Portable FAR Infrared Sauna Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart

FDA device recall Z-1541-2015 · posted 2015-04-28 · Terminated

Recall details

Recalling firm

Therasage, LLC.

Reason for recall

Product distributed without 510(k) approval

Action taken

On January 20, 2015 Therasage sent a notification to its consignees asking them to discard any of the labeling materials that state the following: 1) Use of the sauna allows one to "naturally detoxify." 2) Use of the sauna expels toxins from the body 3) Any reference to an exact amount of calories one uses in an hour when enjoying the benefits of this product 4) Although this product is enhanced with a negative ion environment, we cannot say that the product is enhanced with negative ion therapy 5) Any reference to the maximum infrared absorption available cannot be explicitly stated, as it may vary for each individual person. Customers with questions were instructed to call 888-416-4441 or email info@therasage.com. For questions regarding this recall call 561-416-9300.

Root cause

Labeling False and Misleading

Status

Terminated

Product code

N/A

Quantity affected

8 devices

Distribution

Nationwide Distribution including SD, IL, TX, OR, NY, WI, GA, and CA.

Date initiated

2014-12-23

Date posted

2015-04-28

Date terminated

2015-08-06

Location

Boca Raton, FL