Recall Z-2625-2014— Life Force of Tampa, LLC
Class II · Terminated
Class II FDA medical device recall by Life Force of Tampa, LLC, initiated 2014-06-27, terminated 2015-07-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Life Force Chamber Product Usage:The product is intended for restful contemplation and spirituality.. Reason: The Life Force chamber is marketed and promoted as a medical device, intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. Life Force of Tampa does not have an approved application for premarket approval in effect, or an approved application for an investigat.
- Recalling firm
- Life Force of Tampa, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-06-27
- Terminated
- 2015-07-30
- Firm location
- Tampa, FL, United States
Product description
Life Force Chamber Product Usage:The product is intended for restful contemplation and spirituality.
Reason for recall
The Life Force chamber is marketed and promoted as a medical device, intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. Life Force of Tampa does not have an approved application for premarket approval in effect, or an approved application for an investigat
Data sourced from openFDA. This site is unofficial and independent of the FDA.