StacksVerified U.S. regulatory reference

21 CFR §890.5850

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
  1. (a)Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.
  2. (b)Classification. Class II (performance standards).