Section 880.6450 - Skin pressure protectors(a)Identification. A skin pressure protector is a device intended for medical purposes that is used to reduce pressure on the skin over a bony prominence to reduce the likelihood of the patient's developing decubitus ulcers (bedsores).(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 § 880.9 . The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 , with respect to general requirements concerning records, and § 820.198 , with respect to complaint files.45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38806 , July 25, 2001