21 CFR 890.5710 - Hot or cold disposable pack.

§ 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.

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

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United States Code