(a) Identification. A powered nasal irrigator is an AC-powered device intended to wash the nasal cavity by means of a pressure-controlled pulsating stream of water. The device consists of a control unit and pump connected to a spray tube and nozzle.
(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 Sec. 874.9. [55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2316, Jan. 14, 2000]