Device product
Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)
Z-0348-2020
Product summary
- Firm
- Basic Reset Inc.
- Event
- Event 84117
- Status
- Completed
- Classification
- Class II
- Quantity
- 1257 units
- Official record key
device-enforcement:Z-0348-2020
Official wording
Reason: FDA determined that marketing claims surrounding product rendered product a medical device which was adulterated and misbranded.
Code information: All product distributed between November 7, 2017 to September 4, 2019
Distribution pattern: US, Puerto Rico, U.S. Virgin Islands, Canada, Mexico, Australia, PHILIPPINES, Greece, United Kingdom, Israel, Nigeria, Hungary, United Arab Emirates
Derived failure modes
-
Labeling or packaging
misbranded