---
kind: "section"
citation: "21 C.F.R. § 890.5150"
title: "21"
number: "890.5150"
heading: "Powered patient transport."
url: "https://uscodex.org/cfr/21/890.5150"
---

# §890.5150. Powered patient transport.

- (a) **Powered patient stairway chair lifts—**
  - (1) **Identification.** A powered patient stairway chair lift is a motorized lift equipped with a seat and permanently mounted in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by moving a person up and down a stairway.
  - (2) **Classification.** Class II. The stairway chair lift is exempt from premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter, subject to [§ 890.9](/cfr/21/890.9.md) and the following conditions for exemption:
    - (i) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of American Society of Mechanical Engineers (ASME) A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate that the safety controls are adequate to prevent a free fall of the chair in the event of a device failure;
    - (ii) Appropriate analysis and nonclinical testing must demonstrate the ability of the device, including armrests, to withstand the rated load with an appropriate factor of safety;
    - (iii) Appropriate restraints must be provided to prevent the user from falling from the device (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”);
    - (iv) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized editions of AAMI/ANSI/IEC 60601-1-2, “Medical Electrical Equipment—[Part 1-2](/cfr/21/part1-2.md): General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests,” and ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must validate electromagnetic compatibility and electrical safety; and
    - (v) Appropriate analysis and nonclinical testing must demonstrate the resistance of the device upholstery to ignition.
- (b) **All other powered patient transport—**
  - (1) **Identification.** A powered patient transport is a motorized device intended for use in mitigating mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs (e.g., attendant-operated portable stair-climbing chairs). This generic type of device does not include motorized three-wheeled vehicles or wheelchairs.
  - (2) **Classification.** Class II.

## Notes

### Amendments

[78 FR 14017, Mar. 4, 2013]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 48 FR 53047, Nov. 23, 1983, unless otherwise noted.

### Amendments

[78 FR 14017, Mar. 4, 2013]