510(k) Report

510(k) · Cleared

Cleared

RS-4M+Muscle Stimulator

K000114510(k) TraditionalCleared Aug 10, 2000209-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

Rs Medical · IPF Stimulator, Muscle, Powered

Cleared on Aug 10, 2000 after a 209-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 55 later devices descend from it.

Decided
Aug 10, 2000
Review
209 days
Class
Class II
Product code
IPF
Recalls
None
Predicates
0

55 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2002: 2 descendants cleared2003: 2 descendants cleared2014: 3 descendants cleared2004: 2 descendants cleared2011: 1 descendant cleared2005: 1 descendant cleared2013: 2 descendants cleared2010: 1 descendant cleared2015: 2 descendants cleared2012: 1 descendant cleared2007: 1 descendant cleared2019: 5 descendants cleared2022: 6 descendants cleared2021: 6 descendants cleared2020: 6 descendants cleared2016: 2 descendants cleared2017: 2 descendants cleared2024: 2 descendants cleared2026: 2 descendants cleared2023: 3 descendants cleared2025: 3 descendants cleared200020052010201520202025
  1. This deviceK000114 RS-4M+Muscle StimulatorRs Medical · 2000
  2. Descendant · cites it directly · 48 of its ownK021100 300 PV Complete Electrotherapy SystemEmpi · 2002
  3. Descendant · 2 generations on · 26 of its ownK093324 Empi ContinuumEmpi · 2010
  4. Descendant · 3 generations on · 25 of its ownK124016 Empi PhoenixDjo, LLC · 2013
  5. Descendant · 4 generations on · 24 of its ownK153704 StriveDjo, LLC · 2016
  6. Descendant · 5 generations on · 10 of its ownK170903 Compex Wireless USADjo, LLC · 2017

Showing 5 of 55 descendants. See all descendants

Descendants cleared per year

2002: 22003: 22004: 22005: 12007: 12010: 12011: 12012: 12013: 22014: 32015: 22016: 22017: 22019: 52020: 62021: 62022: 62023: 32024: 22025: 32026: 2
2002high 6 (2020) · low 0 (2006)2026

Most influential descendants

Showing 5 of 55 · See all
  • K021100300 PV Complete Electrotherapy SystemEmpi · 2002 · cites it directly48descendants
  • K093324Empi ContinuumEmpi · 2010 · 2 generations on26descendants
  • K124016Empi PhoenixDjo, LLC · 2013 · 3 generations on25descendants
  • K153704StriveDjo, LLC · 2016 · 4 generations on24descendants
  • K170903Compex Wireless USADjo, LLC · 2017 · 5 generations on10descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000114RS-4M+Muscle StimulatorRs Medical2000—
+1K021100300 PV Complete Electrotherapy SystemEmpi2002—
+2K093324Empi ContinuumEmpi2010—
+3K124016Empi PhoenixDjo, LLC2013—
+4K153704StriveDjo, LLC2016—
+5K170903Compex Wireless USADjo, LLC2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200320
200420
200510
200710
201010
201110
201210
201320
201430
201520
201620
201720
201950
202060
202160
202260
202330
202420
202530
202620
FIG. 1 — Lineage of K000114, 2000–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (55)

See all 55

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

NumberDeviceApplicantDecidedDescendants
K021100300 PV Complete Electrotherapy SystemEmpi200248
K032652RS-4I Muscle Stimulator FamilyRs Medical20034
K021763RS2MI Muscle Stimulator FamilyRs Medical20020

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, K021100 (Empi, 2002) has gone furthest, with 48 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

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—

More from Rs Medical

10 FDA decisions under this applicant name. See the company

  • K112348RS-4I Muscle StimulatorRs Medical · 2012
  • K090951RS- LB Low Back Conductive Garment, Model RS-LBM, RS-LBL, RS-FBG Full Back Conductive Garment , Model RS-FBGRs Medical · 20091 recall
  • K062325RS-4I Muscle Stimulator FamilyRs Medical · 2007
  • K032652RS-4I Muscle Stimulator FamilyRs Medical · 20031 recall
  • K021763RS2MI Muscle Stimulator FamilyRs Medical · 2002

Recent decisions in IPF

The IPF category page

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  • K260142StimelMD (SSMD) systemMotion Informatics ltd. · 2026
  • K251083Compact IIEnraf-Nonius, B.V. · 2025
  • K241433EVE Synergy (EVE-20M)Weero Co., Ltd. · 2025

https://510kreport.com/device/K000114 · printed Nov 5, 2026

Cite this page

510(k) Report. “K000114: RS-4M+Muscle Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K000114

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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