FDA advice concerning Massager “ShoulderFlex” distributed by King International
Case no. 4051/11
FDA is aware of strangulations in these systems and advises to stop using ShoulderFlex.
Distribution is said to be USA.
Regarding possible dealing via Internet, it can not be excluded that some of these systems may also be used in Europe and Germany.
Thus, BfArM forwards this information with reference to the FDA’s advice:
FDA: ShoulderFlex Massager: Warning - Risk of Strangulation
FDA: ShoulderFlex Massager by King International: Safety Communication - Risk of Strangulation
Selbsterdrosselung durch Massagegerät ShoulderFlex Massager
According to the German medical devices act, supervision of users and facilities is a matter of the Federal Competent Authorities.
In case of questions please contact:
Federal Institute for Drugs and Medical Devices
Medical Devices Division
Facsimile: +49 228 207-5300
Telephone: +49 228 207-5306 (Active and in vitro diagnostic medical devices)