21 C.F.R. § 890.3100

Current through November 30, 2024
Section 890.3100 - Mechanical chair
(a)Identification. A mechanical chair is a manually operated device intended for medical purposes that is used to assist a disabled person in performing an activity that the person would otherwise find difficult to do or be unable to do. Examples of mechanical chairs include the following: A chair with an elevating seat used to raise a person from a sitting position to a standing position and a chair with casters used by a person to move from one place to another while sitting.
(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 .

21 C.F.R. §890.3100

48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994; 66 FR 38816 , July 25, 2001