Z-2625-2014 Class II Terminated
FDA device recall Z-2625-2014 was initiated by Life Force of Tampa, LLC on June 27, 2014 and is designated Class II. 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, o… The recall status is terminated (terminated July 30, 2015). Affected quantity: 10.
Recall Details
- Product Type
- Devices
- Report Date
- September 17, 2014
- Initiation Date
- June 27, 2014
- Termination Date
- July 30, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10
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
Distribution Pattern
Nationwide Distribution in the states of AZ, FL, MD, NV, OK, PA, and TX.
Code Information
ALL Life Force Chambers