Recall Z-1811-2017— 2k Innovations Inc.

Name: FDA recall Z-1811-2017
Creator: U.S. Food and Drug Administration
Published: 2016-04-15

Class II · Terminated

Class II FDA medical device recall by 2k Innovations Inc., initiated 2016-04-15, terminated 2019-08-07. FDA's recall record names no specific 510(k) clearance for this event. Product: Volt Resistance Heated Slipper Gray (All sizes) Deep penetrating heat garment and wraps. Reason: During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website..

Recalling firm: 2k Innovations Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-04-15
Terminated: 2019-08-07
Firm location: Saint Augustine, FL, United States

Product description

Volt Resistance Heated Slipper Gray (All sizes) Deep penetrating heat garment and wraps

Reason for recall

During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.

Data sourced from openFDA. This site is unofficial and independent of the FDA.