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U.S. Department of Health and Human Services

Class 2 Device Recall Portable FAR Infrared Sauna

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  Class 2 Device Recall Portable FAR Infrared Sauna see related information
Date Initiated by Firm December 23, 2014
Date Posted April 28, 2015
Recall Status1 Terminated 3 on August 06, 2015
Recall Number Z-1541-2015
Recall Event ID 70737
Product Classification unknown device name - Product Code N/A
Product Portable FAR Infrared Sauna
Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .
Code Information PS2002
Recalling Firm/
Manufacturer		 Therasage, LLC.
21000 Boca Rio Rd Ste A21c
Boca Raton FL 33433-1504
For Additional Information Contact Robert Besner
561-416-9300
Manufacturer Reason
for Recall		 Product distributed without 510(k) approval
FDA Determined
Cause 2		 Labeling False and Misleading
Action 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.
Quantity in Commerce 8 devices
Distribution Nationwide Distribution including SD, IL, TX, OR, NY, WI, GA, and CA.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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