Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1540-2015 — FAR-Infrared Heat Home Sauna, 3 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .

U.S. FDA — Device Enforcement · United States · 2014-12-23 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1540-2015
Date of alert: 2014-12-23
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Therasage, LLC.
Product category: device
Product type: Devices

Reported risk: Product distributed without 510(k) approval

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1540-2015 — FAR-Infrared Heat Home Sauna, 3 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .

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