U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
원인
Medical device marketed without marketing approval for claims that include strengthening, recharging and removing toxins from cells.
조치
Customers were notified by letter on September 16, 2008 and were told to discontinue use as a medical device. This letter notification included:
1. A warning label to be placed on the Vibe machine stating that it is not a medical device and should not be used as such;
2. An updated operation manual/users guide containing no medical conditions or human body claims; and
3. A certification to be signed by the user and returned acknowledging receipt of the letter; affixed the warning label; will not promote the Quantum Pulse as a medical device; will remove any medical claims from their website; destroy any Quantum Pulse literature making medical claims and destroy any previous operation manual/user guides.
Please contact VIBE Technologies at 800-356-9594 for questions or need assistance in complying with these actions.