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Recall Observatory FDA recall evidence

Device product

Life Force Chamber Product Usage:The product is intended for restful contemplation and spirituality.

Z-2625-2014

June 27, 2014

Class II

Product summary

Firm
Life Force of Tampa, LLC
Event
Event 69043
Status
Terminated
Classification
Class II
Quantity
10
Official record key
device-enforcement:Z-2625-2014

Official wording

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

Code information: ALL Life Force Chambers

Distribution pattern: Nationwide Distribution in the states of AZ, FL, MD, NV, OK, PA, and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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