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Why does the U.S. FDA regulate electrical muscle stimulators?

Electrical muscle stimulators are considered devices under the Federal Food, Drug, and Cosmetic Act. Under this law and the agency's regulations, the FDA is responsible for regulating the sale of all electrical muscle stimulators in the United States. Therefore, firms must comply with appropriate FDA pre-market regulatory requirements before they can legally sell their stimulators.  If a company wants to sell EMS devices directly to consumers, the company needs to show FDA it can be used safely and effectively in that setting. Only after receiving the clearance from the FDA, companies can start selling and distributing their products in the USA.

What is the Interval /HIIT program?

Is it real exercise?

Why do you not recommend it for women over 16 stone 224lbs /101kg?

Will it fit me? do the wraps come in different sizes?

Is this like those ab-toners?

Do the pads need to be replaced?

Can it help me lose weight?

Can I do a marathon on the couch?

Can I use it at 'easy' levels?

What is the difference between Standard and PRO?

What are Zones?