StacksVerified U.S. regulatory reference

21 CFR §890.5660

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
  1. (a)Identification. A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.
  2. (b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.