Import Alert 89-01

"Electrical Muscle Stimulators and Iontophoresis Devices"

The use of these electrical devices in health clubs, beauty salons and figure salons has been increasing for several years. While there are legitimate uses for both muscle stimulators and iontophoresis devices, they are prescription devices and are misbranded when labeled for lay use. In addition, 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.

A large number of these products are imported from firms identified in the Red List. The following information is provided to aid the districts in identifying and detaining misbranded muscle stimulators and iontophoresis devices.

Muscle Stimulators:

Electrical muscle stimulators are prescription devices used to repeatedly contract muscles by passing electrical currents through electrodes in contact with the body. One or more pairs of electrodes, along with creams or gels, may accompany the device, which may be powered by battery or line voltage. There are currently no acceptable uses for these devices when labeled for over the counter use. When labeled for Rx use by a licensed practitioner, the following uses are generally recognized as acceptable:

1. Relaxation of muscle spasm.

2. Prevention or retardation of disuse atrophy.

3. Muscle reeducation.

4. Increasing local blood circulation.

5. Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.

6. Maintaining or increasing range of motion. The labeling must contain the prescription legend and comply with all the conditions of 21 CFR 801.109.

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.

Iontophoresis Devices:

An iontophoresis device is a prescription device used to introduce ions of soluble salts (i.e., medications) by use of direct current into the tissues of the body for therapeutic or diagnostic purposes.

There are currently no acceptable uses for iontophoresis devices when they are labeled for over the counter use. When labeled for Rx use by a licensed practitioner, the only approved use is the diagnosis of cystic fibrosis explained in the final classification 21 CFR Part 890.5525, * or for use with a drug, if labeling includes adequate directions for use of the device with that drug.*

All other uses would result in the device being considered Class III, requiring premarket approval.

The labeling for this device must contain the prescription legend and comply with all the required information of 21 CFR 801.109.

The names of these devices, the names of the companies and the labeling claims may change in the future. Some devices are being promoted for both muscle stimulation and iontophoresis. There is no objection to combined labeling or use as long as the labeling requirements for both uses are met and FDA has determined it to be substantially equivalent to preamendment electrical muscle stimulators and iontophoresis devices.

Consult the Center for Devices and Radiological Health (HFZ 343), Edgardo Santiago about appropriate charges, adequate warnings, and whether detention is warranted.

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301 796-5992.

Electrical Muscle Stimulators and Iontophoresis Devices

Devices lacking prescription legend or otherwise not in compliance with 21 CFR 801.109:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a prescription device labeled for lay use, and thus lacks adequate directions for its use [Misbranded, 502(f)(1)]."

OASIS charge code - RX DEVICE

Devices with inappropriate claims:

"The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to lack adequate directions for its intended use [Misbranded, 502(f)(1)]."

OASIS charge code - DIRECTIONS


Devices with labeling claims that are false and misleading:

"The article is subject to refusal of admission pursuant to section 801(a)(3) in that its labeling appears to be false or misleading [Misbranded, 502(a)]."

OASIS charge code - FALSE


Devices marketed without premarket notification:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears that a premarket notification was not submitted pursuant to section 510(k) [Misbranded, 502(o)]."

OASIS charge code - NO 510(K)


Charges may be combined as appropriate.

Note: Depending on the actual electromechanical configuration of the device it may also be misbranded within the meaning of Section 502(f)(2).