Section 890.3410 - External limb orthotic component(a)Identification. An external limb orthotic component is a device intended for medical purposes for use in conjunction with an orthosis (brace) to increase the function of the orthosis for a patient's particular needs. Examples of external limb orthotic components include the following: A brace-setting twister and an external brace stirrup.(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 § 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 § 820.180 , regarding general requirements concerning records and § 820.198 , regarding complaint files.48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816 , July 25, 2001