StacksVerified U.S. regulatory reference

21 CFR §868.5440

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
  1. (a)Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).
  2. (b)Classification. Class II (performance standards).