Cold pack.

21 C.F.R. § 890.5700
in effectEffective: 2024-07-01
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(a) Identification. A cold pack is a device intended for medical purposes that consists of a compact fabric envelope containing a specially hydrated pliable silicate gel capable of forming to the contour of the body and that provides cold therapy for body surfaces. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807. The device also is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

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