(a) Identification. A Denis Brown splint is a device intended for medical purposes to immobilize the foot. It is used on young children with tibial torsion (excessive rotation of the lower leg) or club foot.
(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 66 FR 38817, July 25, 2001]