BioLeonhardt Whole Body

BodStim Bioelectric Suit

Wellness Accelerated™
Jumpstart your health and longevity journey with BodStim

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BodStim is a whole-body bioelectric bodysuit designed to augment the effects of exercise to help you achieve better results in less time.

BodStim TM by Wiemspro is a whole-body bioelectric EMS (electrical muscle stimulation) body suit designed for healthy subjects (not for medical use) to augment the effects of exercise to help you achieve better exercise output results such as building muscle in less time than normal exercise. The BodStim TM electrical signaling program within the Wiemspro stimulator app is designed to enhance muscle building with specific signals.

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Muscle Exercise May Promote Healthy Aging and Longevity

As we age, we lose muscle mass, which by many studies is deemed to essential to long-term wellness and injury prevention. BodStim TM by Wiemspro helps people increase their muscle mass quickly as they build strength, flexibility, and overall fitness. The best results should come from regular consistent exercise accompanied by eating health foods, healthy sleeping and breathing habits, stress management and maintaining good gut and brain health.

The BodStim TM software program loaded into the Wiemspro EMS suit stimulator is available FOR INVESTIGATIONAL RESEARCH USE ONLY

Examples of Types Research Forms Needed to be Completed…

            Three configurations of BodStim bioelectric suits are available:

BodStim

Designed for personal use

  • Comfortable stretch two-piece bodysuit – similar to a cycling suit
  • Electrodes are placed at strategic locations throughout the suit to send muscle contraction and bioelectric signals
  • Cables are integrated into the bodysuit’s comfortable stretch fabric and do not touch the skin
  • Simultaneously works multiple muscle groups: extensors, gluteals, abductors, hamstrings, abdominals, obliques, quadriceps, calves, biceps, and triceps.
  • A small, portable stimulator fits snuggly in a connector pocket on the pants
  • Programs are pre-loaded to run at the touch of a button
  • Multiple sizes available – XXS to XXL
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BodStim Pro

Designed for use by multiple people in training environments and wellness spas

  • Clip-on vests and trousers are available in a wide range of sizes to fit various body shapes – XXS to XXL
  • The Pro suit is worn over BodStim undergarments
  • Electrode placement can be adapted to each client’s body shape
  • Small, portable stimulator fits snuggly in connector pocket
  • A trainer can control the wireless program via a mobile app
  • The Pro suit is sanitized after each use
  • BodStim Pro can be washed up to 10,000 times
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BodStim Fit

Designed for personal use

  • Yoga-type long pants for personal use
  • Designed to tone and reshape the body
  • Simultaneously works multiple muscle groups
  • A small, portable stimulator fits snuggly in a connector pocket on the pants
  • Programs are pre-loaded to run at the touch of a button
  • Multiple sizes available
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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, 

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 [email protected]   
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.