Misbranded and/or Adulterated Powered Muscle Stimulators and Iontophoresis Devices

Why FDA issued it

Note: The revision of this Import Alert (IA) dated 02/23/2022 updates the name of the alert, removes "surveillance" from alert type and changes to firm alert, updates the existing reason for alert and guidance section, agency contacts, PAF and PAC codes, updates charge code language, and adds new charge. Changes to the import alert are bracketed by asterisks (***). ***The use of these electrical devices in health clubs, beauty salons and figure salons has been increasing for several years. While there are legitimate over-the-counter and prescription Indications for Use for both powered muscle stimulators (e.g., muscle reeducation, relief of muscle spasm, increasing range of motion, disuse atrophy therapy, increased local blood circulation, or immediate post-surgical stimulation of calf muscles to prevent venous thrombosis) and iontophoresis devices (e.g., inducing sweating for use in the

Quoted from the “Reason for Alert” section of the FDA page for 89-01, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.