(a) Identification. A nonpowered communication system is a mechanical device intended for medical purposes that is used to assist a patient in communicating when physical impairment prevents writing, telephone use, reading, or talking. Examples of nonpowered communications systems include an alphabet board and a page turner.
(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 Sec. 890.9. 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 Sec. 820.180, regarding general requirements concerning records and Sec. 820.198, regarding complaint files. [48 FR 53047, Nov. 23, 1983, as amended at 54 FR 25052, June 12, 1989; 66 FR 38817, July 25, 2001]