21 C.F.R. § 890.5700 Cold pack.
Title 21 - Food and Drugs
(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 regulations in part 820, with the exception of §820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files.
Title 21: Food and Drugs
PART 890—PHYSICAL MEDICINE DEVICES
Subpart F—Physical Medicine Therapeutic Devices
§ 890.5700 Cold pack.
