View all text of Subpart D [§ 878.3250 - § 878.3925]
§ 878.3900 - Inflatable extremity splint.
(a) Identification. An inflatable extremity splint is a device intended to be inflated to immobilize a limb or an extremity.
(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 § 878.9.