(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  § 890.9.
     
    
        
            Code of Federal Regulations
        
        [48 FR 53047, Nov. 23, 1963, as amended at 65 FR 2322, Jan. 14, 2000]