510(k) Report

FDA product code · Physical medicine

Table, Physical Therapy, Multi Function

JFBClass II21 CFR 890.5880510(k) required66 decisions since 19820 recalls

66 FDA decisions since 1982. 510(k) reviews decided 2021–2025 took a median of 166 days (half between 93 and 220). No recall names this code. The most-cited predicate is K040031, named by 4 later devices.

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 JFB 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 · JFB

3in 2025

2007: 12008: 12010: 22011: 22012: 22014: 12016: 12021: 22022: 12024: 22025: 3
2007high 3 (2025) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JFB

162in 2025

2025: 162 days median
2007high 162 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JFB

No recall names JFB since 2007.

Adverse event reports per year · JFB

1in 2024

2007: 32008: 32009: 32010: 12011: 12012: 22013: 22020: 12022: 22024: 1
2007high 3 (2007) · low 0 (2014)2025

MAUDE reports naming product code JFB, 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
20071—03
20081—03
20090—03
20102—01
20112—01
20122—02
20130—02
20141—00
20150—00
20161—00
20170—00
20180—00
20190—00
20200—01
20212—00
20221—02
20230—00
20242—01
2025316200
20260—0—
FIG. 1 — JFB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JFB? 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