Recall Z-0348-2020— Basic Reset Inc.
Class II · Completed
Class II FDA medical device recall by Basic Reset Inc., initiated 2019-10-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B). Reason: FDA determined that marketing claims surrounding product rendered product a medical device which was adulterated and misbranded..
- Recalling firm
- Basic Reset Inc.
- Classification
- Class II
- Status
- Completed
- Initiated
- 2019-10-18
- Firm location
- Hendersonville, TN, United States
Product description
Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)
Reason for recall
FDA determined that marketing claims surrounding product rendered product a medical device which was adulterated and misbranded.
Data sourced from openFDA. This site is unofficial and independent of the FDA.