(a) Identification. A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.
(b) Classification. Class I (general controls). Except when intended for use on infants, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 890.9. [48 FR 53047, Nov. 23, 1963, as amended at 65 FR 2322, Jan. 14, 2000]