Muscle Stimulators, Do They Work? (cont.)

Question: What does FDA regulation accomplish?

Firms that market EMS devices are required to comply with appropriate FDA premarket regulatory requirements before they may legally sell their devices. The firm must be able to demonstrate that these devices are as safe and as effective as similar devices that are legally marketed. Devices may only be marketed for uses that are established for the device or for uses that the firm can support with data. At this time, FDA is not aware of scientific information to support many of the promotional claims being made for numerous devices being widely promoted on television, infomercials, newspapers, and magazines.

Question: Why should I select an electrical muscle stimulator that is legally marketed according to FDA regulations?

Electrical Muscle Stimulators that have not met FDA premarket requirements are illegal, and the FDA has not determined whether or not they are properly designed, manufactured, and labeled to provide reasonable assurance that they are safe and effective.

Question: Does that mean that it's unsafe to use an electrical muscle stimulator that has not met FDA requirements?

Using a product that has not met FDA requirements isn't necessarily unsafe or dangerous. But it could be. FDA has received reports of shocks, burns, bruising, skin irritation, pain, and interference with other critically important medical devices (e.g., pacemakers) associated with the use of unregulated products. Unregulated devices also may have safety problems associated with cables and leads that can lead to accidental shock and electrocution by users and other household members, including children.

Question: If I use an electrical muscle stimulator that has met FDA regulatory requirements, will it give me the same kind of effect that lots of sit-ups, stomach crunches and other abdominal exercises will?

Using these devices alone will not give you "six-pack" abs. Applying electrical current to muscles may cause muscles to contract. Stimulating muscles repeatedly with electricity may eventually result in muscles that are strengthened and toned to some extent but will not, based on currently available data, create a major change in your appearance without the addition of diet and regular exercise.

Question: But hasn't FDA cleared electrical muscle stimulators to treat medical conditions?

Yes. The FDA has cleared many electrical muscle stimulators for prescription use in treating medical conditions. Doctors may use electrical muscle stimulators for patients who require muscle re-education, relaxation of muscle spasms, increased range of motion, prevention of muscle atrophy, and for treating other medical conditions which usually result from a stroke, a serious injury, or major surgery. Again, the effect of using these devices is primarily to help a patient recover from impaired muscle function due to a medical condition, not to increase muscle size enough to affect appearance.

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