21 C.F.R. § 890.5730 Moist heat pack.
Title 21 - Food and Drugs
(a) Identification. A moist heat pack is a device intended for medical purposes that consists of silica gel in a fabric container used to retain an elevated temperature and that provides moist heat 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 of this chapter, subject to the limitations in §890.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of §820.180, regarding general requirements concerning records and §820.198, regarding complaint files. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38818, July 25, 2001]
Title 21: Food and Drugs
PART 890—PHYSICAL MEDICINE DEVICES
Subpart F—Physical Medicine Therapeutic Devices
§ 890.5730 Moist heat pack.
