U.S. FDA 510K 181955 Market Clearance
Indications for Use: See Wiemspro FDA 510K Market Clearance Letter Link here for exact and only indications of use for the the BodStim TM by Wiempro EMS Suit > https://www.accessdata.fda.gov/cdrh_docs/pdf18/K181955.pdf
BodStim by Wiemspro is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The BodStim by Weimspro is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of BodStim by Weimspro training programs are designed for injured or ailing muscles and its use on such muscles is contraindicated.
BodStim by Wiemspro is a machine with electronic muscle stimulation based on EMS technology. Regarding its use, the device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes.
BodStim by Wiemspro electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations of motoneurons are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.
Investigational Use & Regulatory Compliance: Any other use other than that mentioned above will be for Investigational Use Only and requires Institutional Review Board (IRB) and Ethics Committee advance approval and may require FDA clearance ahead of enrollment with an approved patient consent form and clinical protocol. Such studies will also require proper controls in place including a secure database and an assigned Principal Investigator and may requite an independent Data & Safety Monitoring Board (DSMB) with authority to discontinue enrollment at any time. All clinical sites must meet strict established minimum criteria to enroll patients and must be trained and be ready to implement properly Adverse Event Reporting, when needed.
Many of our distributed products are considered general wellness products and as such may not be evaluated by the US Food and Drug Administration. Lionheart Health general wellness and beauty products are not intended to diagnose, treat, cure, or prevent any disease or condition. Sufficient clinical data has not been gathered yet to support medical treatment applications. If you want to receive exact regulatory status of any specific product or treatment please email cs@lionhearthealthstim.com
FDA 510K Clearance Details Our Mettler Electronics of Anaheim, California (in business since 1957) benchtop stimulators to be used with skin/muscle electrodes have FDA 510K clearance https://www.accessdata.fda.gov/cdrh_docs/pdf11/K113017.pdf only for improving circulation, pain & inflammation relief, arthritis treatment, blood clot prevention after surgery and muscle recovery. Our EMS suit has FDA clearance for augmenting the benefits of exercise especially in building more muscle more quickly than normal exercise. Our Saebo portable stimulator adds an FDA clearance for stroke recovery stimulation in addition to improving circulation and muscle recovery. All prescription use only for use under the supervision of a trained professional. Please read the link above to the actual 510K file to understand exact indications of use cleared.
Note: BodStim TM and Lionheart Health only provide distribution, software protocol and research support to Wiemspro Spain and Mettler Electronics, Inc of Anaheim, California for their skin/muscle stimulation based devices. BodStim Tm and Lionheart Health are not manufacturers of the devices. The BodStim TM and Lionheart Health teams have sponsored many pre-clinical and clinical studies with these devices and continues to do so now.
BodStim TM signaling sequence software within these stimulation devices is investigational use only at this time.