21 C.F.R. § 890.5710

Current through October 31, 2024
Section 890.5710 - Hot or cold disposable pack
(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 .

21 C.F.R. §890.5710

48 FR 53047, Nov. 23, 1963, as amended at 65 FR 2322 , Jan. 14, 2000