FDA product code · Physical medicine

Interactive Rehabilitation Exercise Device, Prescription Use

Name: FDA decisions, review times, recalls and adverse event reports for product code QKC
Creator: 510(k) Report

QKCClass II21 CFR 890.5360510(k) exempt0 decisions0 recalls

FDA lists QKC 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. No recall names this code.

A prescription device intended to provide interactive rehabilitation environment by providing exercises for users to perform.

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 QKC 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.

FIG. 1 — QKC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QKC? 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

Related product codes

Other codes under 21 CFR 890.5360.

ISD Exerciser, Measuring LXJ Interactive Rehabilitation Exercise Devices