510(k) · Cleared

Cleared

IF-II (TM), Model 7200

K923914510(k) TraditionalCleared Nov 6, 199298-day reviewClass II21 CFR 890.5850

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

Medical Devices, Inc. · IPF Stimulator, Muscle, Powered

Cleared on Nov 6, 1992 after a 98-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 61 later devices descend from it.

Decided: Nov 6, 1992
Review: 98 days
Class: Class II
Product code: IPF
Recalls: None
Predicates: 0

61 later devices descend from it, 2 citing it directly.

This deviceK923914 IF-II (TM), Model 7200Medical Devices, Inc. · 1992
Descendant · cites it directly · 56 of its ownK050046 Rehabilicare IF 3 Wave Interferential Stimulator System, Model 7110SCompex Technologies, Inc. · 2005
Descendant · 2 generations on · 26 of its ownK093324 Empi ContinuumEmpi · 2010
Descendant · 3 generations on · 25 of its ownK124016 Empi PhoenixDjo, LLC · 2013
Descendant · 4 generations on · 24 of its ownK153704 StriveDjo, LLC · 2016
Descendant · 2 generations on · 19 of its ownK123354 Revitive IXActegy, Ltd. · 2013

Showing 5 of 61 descendants. See all descendants

Descendants cleared per year

2003high 8 (2020) · low 0 (2004)2026

Most influential descendants

Showing 5 of 61 · See all

K050046Rehabilicare IF 3 Wave Interferential Stimulator System, Model 7110SCompex Technologies, Inc. · 2005 · cites it directly56descendants
K093324Empi ContinuumEmpi · 2010 · 2 generations on26descendants
K124016Empi PhoenixDjo, LLC · 2013 · 3 generations on25descendants
K153704StriveDjo, LLC · 2016 · 4 generations on24descendants
K123354Revitive IXActegy, Ltd. · 2013 · 2 generations on19descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K923914	IF-II (TM), Model 7200	Medical Devices, Inc.	1992	—
+1	K050046	Rehabilicare IF 3 Wave Interferential Stimulator System, Model 7110S	Compex Technologies, Inc.	2005	—
+2	K093324	Empi Continuum	Empi	2010	—
+3	K124016	Empi Phoenix	Djo, LLC	2013	—
+4	K153704	Strive	Djo, LLC	2016	—
+2	K123354	Revitive IX	Actegy, Ltd.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	1	0
2006	1	0
2007	2	0
2009	1	0
2010	1	0
2013	2	0
2015	1	0
2016	1	0
2017	7	0
2018	2	0
2019	7	0
2020	8	0
2021	4	0
2022	3	0
2023	6	0
2024	3	0
2025	6	0
2026	4	0

FIG. 1 — Lineage of K923914, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IPF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new IPF device

#1 K241433 EVE Synergy (EVE-20M)score 19.7 · 25 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (61)

See all 61

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K050046	Rehabilicare IF 3 Wave Interferential Stimulator System, Model 7110S	Compex Technologies, Inc.	2005	56
K030998	Medrelief SE Series, Models SE-50, SE-100, SE-200, SE-300	Healthonics, Inc.	2003	3

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K050046 (Compex Technologies, Inc., 2005) has gone furthest, with 56 descendants of its own.

How does its category compare?

All IPF devices

IPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IPF

3in 2025

2007high 15 (2021) · low 3 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IPF

257in 2025

2007high 275 (2011) · low 43 (2015)2026

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

Recalls per year · IPF

1in 2023

2007high 3 (2012) · low 0 (2007)2026

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

Adverse event reports per year · IPF

8in 2025

2007high 213 (2008) · low 2 (2017)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	8	143	0	11
2008	6	140	1	213
2009	7	216	0	150
2010	4	121	0	14
2011	4	275	1	25
2012	4	269	3	16
2013	10	180	0	6
2014	4	264	0	19
2015	3	43	0	11
2016	7	113	0	8
2017	5	110	0	2
2018	5	73	0	3
2019	4	133	0	10
2020	9	121	0	13
2021	15	98	0	3
2022	7	108	0	4
2023	9	255	1	8
2024	7	201	0	5
2025	3	257	0	8
2026	3	206	0	—

https://510kreport.com/device/K923914 · printed Nov 4, 2026

Cite this page

510(k) Report. “K923914: IF-II (TM), Model 7200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K923914

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026