FDA-Device2019-11-20Class II
Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)
Basic Reset Inc.
Hazard
FDA determined that marketing claims surrounding product rendered product a medical device which was adulterated and misbranded.
Sold states
US, Puerto Rico, U.S. Virgin Islands, Canada, Mexico, Australia, PHILIPPINES, Greece, United Kingdom, Israel, Nigeria, Hungary, United Arab Emirates
Affected count
1257 units
Manufactured in
260 W Main St Ste 103, N/A, Hendersonville, TN, United States
Products
Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0348-2020Don't want to check this manually?
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