510(k) Report

FDA product code · Physical medicine

Powered Stairway Chair Lift

PCDClass II21 CFR 890.5150510(k) exempt0 decisions1 recall

FDA lists PCD as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 890.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. 1 recall names this code; it is not Class I.

A powered patient stairway chair lift (Stair Machine) 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

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, physical medicine panel

Twenty years of PCD at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · PCD

FDA has decided no PCD device since 2007.

Median 510(k) review, days · PCD

Too few PCD 510(k)s in any year since 2007 to give a median.

Recalls per year · PCD

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · PCD

19in 2025

2014: 162015: 122016: 92017: 122018: 122019: 162020: 92021: 202022: 212023: 212024: 152025: 19
2007high 21 (2022) · low 0 (2007)2025

MAUDE reports naming product code PCD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—016
20150—012
20160—19
20170—012
20180—012
20190—016
20200—09
20210—020
20220—021
20230—021
20240—015
20250—019
20260—0—
FIG. 1 — PCD by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PCD? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

What has been recalled in PCD lately?

  • Z-0681-2022Acorn 130 Stairlift, Brooks 130 Stairlift, Acorn 180 Stairlift, and Acorn Outdoor…Acorn Stairlifts, Inc · Apr 20, 2016Class II

Related product codes

Other codes under 21 CFR 890.5150.

ILK Transport, Patient, Powered