(a) Identification. A noninflatable extremity splint is a device intended to immobilize a limb or an extremity. It is not inflatable.

(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 §878.9. If the device is not labeled or otherwise represented as sterile, it is 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 of this chapter, with respect to general requirements concerning records, and §820.198 of this chapter, with respect to complaint files.

[53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 65 FR 2317, Jan. 14, 2000]