StacksVerified U.S. regulatory reference

21 CFR §890.5740

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
  1. (a)Identification. A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for body surfaces. It is capable of maintaining an elevated temperature during use.
  2. (b)Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E part 807 of this chapter subject to § 890.9.