Class 2 Device Recall Energy FX

• Date Initiated by Firm: October 18, 2019
• Create Date: November 08, 2019
• Recall Status: Completed
• Recall Number: Z-0348-2020
• Recall Event ID: 84117
• Product Classification: unknown device name - Product Code N/A
• Product: Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)
• Code Information: All product distributed between November 7, 2017 to September 4, 2019
• FEI Number: 3007197806
• Recalling Firm/ Manufacturer: Basic Reset Inc.; 260 W Main St Ste 103; Hendersonville TN 37075-7316
• For Additional Information Contact: Mr. Fred Kaufman; 615-469-2222
• Manufacturer Reason for Recall: FDA determined that marketing claims surrounding product rendered product a medical device which was adulterated and misbranded.
• FDA Determined Cause: No Marketing Application
• Action: The firm initiated the recall on 09/23/2019 by email and followed with a second letter on 10/18/2019. The letter requests the consignee discard/destroy the product.
• Quantity in Commerce: 1257 units
• Distribution: US, Puerto Rico, U.S. Virgin Islands, Canada, Mexico, Australia, PHILIPPINES, Greece, United Kingdom, Israel, Nigeria, Hungary, United Arab Emirates

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.