Lionheart HTM OUS Export Products

(Available Only for Investigational Use in the USA)

Lionheart HTM Products
Available for Sale OUS (Investigational Use Only in the USA with IRB Approval and Patient Consent)

Lionheart HTM MedSpa and Sports Medicine Physio Therapy Products are of the highest quality. Manufactured for Lionheart Health, Inc. by High Tech Medical (HTM) Electronics Brazil (Est. 1999). HTM Electronics sells over $127 million of these products annually OUS primarily in Brazil as a leading high quality manufacturer. The Lionheart Health, Inc. patented bioelectric signaling sequences improve the performance results with many of the HTM products as confirmed in pre-clinical and clinical testing. Lionheart Health, Inc. is sponsoring the registration of these products with the FDA via 510K filings and Cosmetic Regulations. In certain circumstances they may be available now in the USA for low risk (Non-Significant Risk – FDA guidance link here https://www.fda.gov/media/75459/download) clinical evaluations or studies for skin, hair, body toning with proper IRB approval in place and patient consent properly followed.

Before and After Clinical Results with HTM Products

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Lionheart HTM MedSpa Products Catalog > Click Here
Lionheart HTM Sports Medicine Physio Therapy Catalog > Click Here
Lionheart HTM High Ticket OUS Export Price List > Click Here
Lionheart HTM Low Ticket OUS Export Price List > Click Here

Many of Lionheart Health 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 [email protected]   
Our benchtop stimulators have FDA 510K clearance 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.