---
kind: "section"
citation: "21 C.F.R. § 890.3890"
title: "21"
number: "890.3890"
heading: "Stair-climbing wheelchair."
url: "https://uscodex.org/cfr/21/890.3890"
---

# §890.3890. Stair-climbing wheelchair.

- (a) **Identification.** A stair-climbing wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device is intended to climb stairs.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use.
  - (2) Performance testing must demonstrate adequate mechanical performance under simulated use conditions and environments. Performance testing must include the following:
    - (i) Fatigue testing;
    - (ii) Resistance to dynamic loads (impact testing);
    - (iii) Effective use of the braking mechanism and how the device stops in case of an electrical brake failure;
    - (iv) Demonstration of adequate stability of the device on inclined planes (forward, backward, and lateral);
    - (v) Demonstration of the ability of the device to safely ascend and descend obstacles (i.e., stairs, curb); and
    - (vi) Demonstration of ability to effectively use the device during adverse temperatures and following storage in adverse temperatures and humidity conditions.
  - (3) The skin-contacting components of the device must be demonstrated to be biocompatible.
  - (4) Software design, verification, and validation must demonstrate that the device controls, alarms, and user interfaces function as intended.
  - (5) Appropriate analysis and performance testing must be conducted to verify electrical safety and electromagnetic compatibility of the device.
  - (6) Performance testing must demonstrate battery safety and evaluate longevity.
  - (7) Performance testing must evaluate the flammability of device components.
  - (8) Patient labeling must bear all information required for the safe and effective use of the device, specifically including the following:
    - (i) A clear description of the technological features of the device and the principles of how the device works;
    - (ii) A clear description of the appropriate use environments/conditions, including prohibited environments;
    - (iii) Preventive maintenance recommendations;
    - (iv) Operating specifications for proper use of the device such as patient weight limitations, device width, and clearance for maneuverability; and
    - (v) **A detailed summary of the device-related adverse events and how to report any complications.**
  - (9) Clinician labeling must include all the information in the Patient labeling noted in [paragraph (b)(8)](#b-8) of this section but must also include the following:
    - (i) Identification of patients who can effectively operate the device; and
    - (ii) **Instructions on how to fit, modify, or calibrate the device.**
  - (10) Usability studies of the device must demonstrate that the device can be used by the patient in the intended use environment with the instructions for use and user training.

## Notes

### Amendments

[79 FR 20782, Apr. 14, 2014]

### 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

[79 FR 20782, Apr. 14, 2014]