Business ProfileforTummo Studio

BBB sent correspondence to Tummo Studio on September 27, October 11, and October 21, 2022, requesting substantiation for medical and weight loss claims on their website, https://www.tummostudios.com/. 

Some examples of the claims Tummo Studio is making are:
“EMS training combines external electrical stimulation with specially designed exercises allowing you to achieve astonishing results with minimal effort. Simply put, EMS is a health and fitness hack that allows you to build muscle and burn fat in a fraction of the time of conventional training.”
“Supports immune system It’s been shown that moderate endurance sports and targeted muscle development strengthen the body and the immune system. This benefit only comes from training EMS regularly.” 
"20 minutes a week is all it takes to get in shape! The time saving benefits of a whole body EMS workout are unparalleled by anything else this industry. “

BBB's Code of Advertising #34 Claimed Results states:
Claims related to performance, energy savings, safety, efficacy or results for a product or service should be based on recent and competent testing or other objective data.

To date, the business has not responded to our request.

The Miha Bodytec II EMS bodysuit is used by Tummo Studio and has been authorized by the FDA as a muscle training device. According to FDA 510 K201975, the Miha Bodytec II 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.
Miha Bodytec II is intended to stimulate muscles in order to improve or facilitate muscle performance. In addition it is indicated for the following conditions:
- Re-educating muscles
- Relaxation of muscle spasm
- Retarding or preventing disuse muscle atrophy
The miha bodytec II 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 claims, such as "burns fat", and "supports immune system", are not an indication of use. According to the FDA, they are prescription devices and "Muscle stimulators are misbranded when any of the following claims are made: girth reduction, loss of inches, weight reduction, cellulite removal, bust development, body shaping and contouring, and spot reducing." Also, "miha bodytec II is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the miha bodytec II training programs are designed for injured or ailing muscles and its use on such muscles is contraindicated."

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-document-powered-muscle-stimulator-510ks-guidance-industry-fda-reviewersstaff-and
The standard indications for use for Powered Muscle Stimulators classified under 21 CFR 890.5850 are:

1.    Relaxation of muscle spasms;

2.    Prevention or retardation of disuse atrophy;

3.    Increasing local blood circulation;

4.    Muscle re-education;

5.    Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and

6.    Maintaining or increasing range of motion.