FDAClass IIMay 6, 2015

Portable FAR Infrared Sauna Indications including recall

Portable FAR Infrared Sauna Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme…

Why was Portable FAR Infrared Sauna Indications including recalled?

Product distributed without 510(k) approval

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

PS2002

Product
Portable FAR Infrared Sauna Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme…
Recalling firm
Therasage, LLC.
Quantity
8 devices
Distribution
Nationwide Distribution including SD, IL, TX, OR, NY, WI, GA, and CA.
Recall date
May 6, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls