510(k) Report

510(k) · Cleared

Cleared

Rehabilicare IF 3 Wave Interferential Stimulator System, Model 7110S

K050046510(k) TraditionalCleared Apr 13, 200593-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

Compex Technologies, Inc. · IPF Stimulator, Muscle, Powered

Cleared on Apr 13, 2005 as substantially equivalent to K926510 (Staodyne, Inc., 1993) and 4 other predicates after a 93-day review. Its family tree reaches back 1 generation to 1987. 56 later devices descend from it.

Decided
Apr 13, 2005
Review
93 days
Class
Class II
Product code
IPF
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K872976 (1987). 5 ancestors in all. 56 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1993: 1 other ancestor1992: 2 other ancestors2017: 7 descendants cleared2010: 1 descendant cleared2013: 2 descendants cleared2009: 1 descendant cleared2019: 7 descendants cleared2015: 1 descendant cleared2018: 2 descendants cleared2016: 1 descendant cleared2020: 8 descendants cleared2023: 6 descendants cleared2025: 6 descendants cleared2021: 4 descendants cleared2024: 3 descendants cleared2026: 4 descendants cleared2022: 3 descendants clearedK872976 · Tens Pals Plus · Axelgaard Mfg. Co., Ltd. · 19871990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 4 descendants2 generations forward: 5 descendants3 generations forward: 9 descendants4 generations forward: 11 descendants5 generations forward: 12 descendants6 generations forward: 14 descendants7 generations forward: 1 descendant K872976 · Tens Pals Plus · Axelgaard Mfg. Co., Ltd. · 19870+5
  1. Root · 1 generation backK872976 Tens Pals PlusAxelgaard Mfg. Co., Ltd. · 1987
  2. This deviceK050046 Rehabilicare IF 3 Wave Interferential Stimulator System, Model 7110SCompex Technologies, Inc. · 2005
  3. Descendant · cites it directly · 26 of its ownK093324 Empi ContinuumEmpi · 2010
  4. Descendant · 2 generations on · 25 of its ownK124016 Empi PhoenixDjo, LLC · 2013
  5. Descendant · 3 generations on · 24 of its ownK153704 StriveDjo, LLC · 2016
  6. Descendant · cites it directly · 19 of its ownK123354 Revitive IXActegy, Ltd. · 2013
  7. Descendant · 2 generations on · 17 of its ownK143207 Revitive IX (OTC)Actegy, Ltd. · 2015

Showing 5 of 56 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12013: 22015: 12016: 12017: 72018: 22019: 72020: 82021: 42022: 32023: 62024: 32025: 62026: 4
2009high 8 (2020) · low 0 (2011)2026

Most influential descendants

Showing 5 of 56 · See all
  • K093324Empi ContinuumEmpi · 2010 · cites it directly26descendants
  • K124016Empi PhoenixDjo, LLC · 2013 · 2 generations on25descendants
  • K153704StriveDjo, LLC · 2016 · 3 generations on24descendants
  • K123354Revitive IXActegy, Ltd. · 2013 · cites it directly19descendants
  • K143207Revitive IX (OTC)Actegy, Ltd. · 2015 · 2 generations on17descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K872976Tens Pals PlusAxelgaard Mfg. Co., Ltd.1987—
0 (this device)K050046Rehabilicare IF 3 Wave Interferential Stimulator System, Model 7110SCompex Technologies, Inc.2005—
+1K093324Empi ContinuumEmpi2010—
+2K124016Empi PhoenixDjo, LLC2013—
+3K153704StriveDjo, LLC2016—
+1K123354Revitive IXActegy, Ltd.2013—
+2K143207Revitive IX (OTC)Actegy, Ltd.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199220
199310
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201320
201510
201610
201770
201820
201970
202080
202140
202230
202360
202430
202560
202640
FIG. 1 — Lineage of K050046, 1987–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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. #1 K241433 EVE Synergy (EVE-20M)score 19.7 · 25 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K926510Staodyn Ems+2
Summary page 2
…nt to the following predicate devices. Predicate Device 510(k Number IClearance Date Staodyne, Inc. EMS+2 Neuromuscular K926510 / August 11, 1993 Devicesiion Systim Medical Inc. Model IF-11 Devices,…
Staodyne, Inc.1993—
*K923914IF-II (TM), Model 7200
Summary page 2
…c. EMS+2 Neuromuscular K926510 / August 11, 1993 Devicesiion Systim Medical Inc. Model IF-11 Devices, K923914 / November 6, 1992 Interferential Stimulation Smstem Stuaoyne,Inc. Model SporTX Pulsed K921668 /aAugust3,…
Medical Devices, Inc.1992—
*K921668Staodyn Tuwave
Summary page 2
…11 Devices, K923914 / November 6, 1992 Interferential Stimulation Smstem Stuaoyne,Inc. Model SporTX Pulsed K921668 /aAugust3, 1992 Dire C ct andurrent TENS Stimulator Axelgaard Manufacturing Company K872976 / September…
Staodyne, Inc.1992—
*K872976Tens Pals Plus
Summary page 2
…em Stuaoyne,Inc. Model SporTX Pulsed K921668 /aAugust3, 1992 Dire C ct andurrent TENS Stimulator Axelgaard Manufacturing Company K872976 / September 22, 1987 TENS Palus Eus Electrides Axelgaard Manufacturing C…
Axelgaard Mfg. Co., Ltd.1987—
*K970426Valuetrode
Summary page 2
…Company K872976 / September 22, 1987 TENS Palus Eus Electrides Axelgaard Manufacturing Company K970426 / May 9, 1997 Valutrod e Electrodes Device Description The IF 3Wave isa non-invasive…
Axelgaard Mfg. Co., Ltd.1997—

Also cleared against K926510: 3 other devices →

What descends from it? (56)

See all 56

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

NumberDeviceApplicantDecidedDescendants
K093324Empi ContinuumEmpi201026
K123354Revitive IXActegy, Ltd.201319
K162987FA100 SCCD (Sequential Continuous Contraction Device)Flowaid Medical Technologies, Corp20175
K090532T.E.a.R. TECH3Vision Quest Industries, Inc.20092

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?

  • None of the 5 ancestors has a recall.
  • Of its descendants, K093324 (Empi, 2010) has gone furthest, with 26 descendants of its own.
  • 3 other devices also cite its predicate K926510.

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

2007: 82008: 62009: 72010: 42011: 42012: 42013: 102014: 42015: 32016: 72017: 52018: 52019: 42020: 92021: 152022: 72023: 92024: 72025: 32026 (partial year): 3
2007high 15 (2021) · low 3 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IPF

257in 2025

2007: 143 days median2008: 140 days median2009: 216 days median2010: 121 days median2011: 275 days median2012: 269 days median2013: 180 days median2014: 264 days median2015: 43 days median2016: 113 days median2017: 110 days median2018: 73 days median2019: 133 days median2020: 121 days median2021: 98 days median2022: 108 days median2023: 255 days median2024: 201 days median2025: 257 days median2026 (partial year): 206 days median
2007high 275 (2011) · low 43 (2015)2026

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

Recalls per year · IPF

1in 2023

2008: 12011: 12012: 32023: 1
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

2007: 112008: 2132009: 1502010: 142011: 252012: 162013: 62014: 192015: 112016: 82017: 22018: 32019: 102020: 132021: 32022: 42023: 82024: 52025: 8
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20078143011
200861401213
200972160150
20104121014
20114275125
20124269316
20131018006
20144264019
2015343011
2016711308
2017511002
201857303
20194133010
20209121013
2021159803
2022710804
2023925518
2024720105
2025325708
202632060—

What is it indicated for?

Interferential stimulation can be used for the following applications: * Relieve acute pain * Relieve and manage chronic pain * Relax muscle spasmns * Maintain and increase the range of motion * Increase local blood circulation Neuromuscular stimulation can be used for the following applications: * Relax muscle spasms * Prevent or retard disuse atrophy * Increase local blood circulation * Re-educate muscles * Maintain or increase the range of motion *…

Read the full statement (134 words)

Interferential stimulation can be used for the following applications:

* Relieve acute pain

* Relieve and manage chronic pain

* Relax muscle spasmns

* Maintain and increase the range of motion

* Increase local blood circulation

Neuromuscular stimulation can be used for the following applications:

* Relax muscle spasms

* Prevent or retard disuse atrophy

* Increase local blood circulation

* Re-educate muscles

* Maintain or increase the range of motion

* Prevent venous thrombosis using immediate postsurgical stimulation on calf muscles

Pulsed direct current stimulation can be used for the following applications:

* Reduction of edema (under negative electrode)

* Reduction of muscle spasm

* Influencing local blood circulation (under negative electrode)

* Retardation or prevention of disuse atrophy

* Facilitation of voluntary motor function

* Maintenance or increase of range of motion

Indications for use as stated in the FDA summary.

Also cleared against K926510

3 other devices cite the same predicate.

  • K024258Neurotech KneehabBio-Medical Research, Ltd. · 2005
  • K041063Smartwave MS 2000Newwave Medical, LLC · 2004
  • K973223Stellar Model HS-04Stellar Medical Corp. · 1998

More from Compex Technologies, Inc.

2 FDA decisions under this applicant name. See the company

  • K061516Staodyn Max Preset, Model 4470Compex Technologies, Inc. · 2007

Recent decisions in IPF

The IPF category page

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  • K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali Nezakati · 2026
  • K260142StimelMD (SSMD) systemMotion Informatics ltd. · 2026
  • K251083Compact IIEnraf-Nonius, B.V. · 2025
  • K241433EVE Synergy (EVE-20M)Weero Co., Ltd. · 2025

https://510kreport.com/device/K050046 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050046: Rehabilicare IF 3 Wave Interferential Stimulator System, Model 7110S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050046

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026