510(k) Report

510(k) · Cleared

Cleared

RS-4I Muscle Stimulator Family

K062325510(k) TraditionalCleared Apr 13, 2007247-day reviewClass II21 CFR 882.5890

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

Rs Medical · NYN Stimulator, Electrical, Transcutaneous, For Arthritis

Cleared on Apr 13, 2007 as substantially equivalent to K032652 (Rs Medical, 2003) and 3 other predicates after a 247-day review. Its family tree reaches back 3 generations to 1997.

Decided
Apr 13, 2007
Review
247 days
Class
Class II
Product code
NYN
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K971437 (1997). 11 ancestors in all, the oldest K923914 (1992). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 3 other ancestors2000: 1 other ancestor2001: 1 other ancestor1998: 1 other ancestor1994: 1 other ancestor1992: 1 other ancestorK971437 · Bionicare Stimulator System. Model Bio-1000 · Murray Electronics · 1997K983228 · Bionicare Stimilator System, Model Bio-1000 · Murray Electronics · 1999K060669 · Medrelief ST Series, Models RT-50, ST-100, ST 150, ST-200, ST-300 · Healthonics, Inc. · 20061990199520002005
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors3 generations back: 4 other ancestors K060669 · Medrelief ST Series, Models RT-50, ST-100, ST 150, ST-200, ST-300 · Healthonics, Inc. · 2006K983228 · Bionicare Stimilator System, Model Bio-1000 · Murray Electronics · 1999K971437 · Bionicare Stimulator System. Model Bio-1000 · Murray Electronics · 19970
  1. Root · 3 generations backK971437 Bionicare Stimulator System. Model Bio-1000Murray Electronics · 1997
  2. 2 generations backK983228 Bionicare Stimilator System, Model Bio-1000Murray Electronics · 1999
  3. 1 generation backK060669 Medrelief ST Series, Models RT-50, ST-100, ST 150, ST-200, ST-300Healthonics, Inc. · 2006
  4. This deviceK062325 RS-4I Muscle Stimulator FamilyRs Medical · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K971437Bionicare Stimulator System. Model Bio-1000Murray Electronics1997—
−2K983228Bionicare Stimilator System, Model Bio-1000Murray Electronics1999—
−1K060669Medrelief ST Series, Models RT-50, ST-100, ST 150, ST-200, ST-300Healthonics, Inc.2006—
0 (this device)K062325RS-4I Muscle Stimulator FamilyRs Medical2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199410
199810
200010
200110
200330
FIG. 1 — Lineage of K062325, 1997–2007Source: 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 NYN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (4)

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
*K032652RS-4I Muscle Stimulator Family
Summary page 1
…- NYN 3. Legally Market Predicate Devices The RS-4i Sequential Stimulator is substantially equivalent to legally marketed devices including the RS-4i model (K032652), the Bionicare Model BIO-1000 (K971437, K030332), and the Healthonics MedRelief ST Series (K060669). 4. Indications for Us…
Rs Medical20031
*K971437Bionicare Stimulator System. Model Bio-1000
Summary page 1
…The RS-4i Sequential Stimulator is substantially equivalent to legally marketed devices including the RS-4i model (K032652), the Bionicare Model BIO-1000 (K971437, K030332), and the Healthonics MedRelief ST Series (K060669). 4. Indications for Use The RS-4i Sequential Stimulator i…
Murray Electronics1997—
*K030332Modification to Bionicare Stimulator System, Model Bio-1000
Summary page 1
…RS-4i Sequential Stimulator is substantially equivalent to legally marketed devices including the RS-4i model (K032652), the Bionicare Model BIO-1000 (K971437, K030332), and the Healthonics MedRelief ST Series (K060669). 4. Indications for Use The RS-4i Sequential Stimulator is indicat…
Bionicare Medical Technologies, Inc.2003—
*K060669Medrelief ST Series, Models RT-50, ST-100, ST 150, ST-200, ST-300
Cleared while this submission was under review
Summary page 1
…lent to legally marketed devices including the RS-4i model (K032652), the Bionicare Model BIO-1000 (K971437, K030332), and the Healthonics MedRelief ST Series (K060669). 4. Indications for Use The RS-4i Sequential Stimulator is indicated for use as adjunctive therapy in reduci…
Healthonics, Inc.2006—

Also cleared against K032652: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
  • 1 of the 11 ancestors has a recall of any class.
  • 2 other devices also cite its predicate K032652.

How does its category compare?

All NYN devices

NYN Stimulator, Electrical, Transcutaneous, For Arthritis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · NYN

1in 2015

2007: 12008: 12011: 12015: 1
2007high 1 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NYN

Too few NYN 510(k)s in any year since 2007 to give a median.

Recalls per year · NYN

No recall names NYN since 2007.

Adverse event reports per year · NYN

1in 2012

2007: 52008: 22011: 12012: 1
2007high 5 (2007) · low 0 (2009)2025

MAUDE reports naming product code NYN, 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—05
20081—02
20090—00
20100—00
20111—01
20120—01
20130—00
20140—00
20151—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The RS-4i Sequential Stimulator is indicated for use as adjunctive therapy in reducing the level of pain associated with osteoarthritis of the knee.

Indications for use as stated in the FDA summary.

Also cleared against K032652

2 other devices cite the same predicate.

  • K112348RS-4I Muscle StimulatorRs Medical · 2012
  • K034005SDS-4ISkylark Device & Systems Co., Ltd. · 2004

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
  • K032652RS-4I Muscle Stimulator FamilyRs Medical · 20031 recall
  • K021763RS2MI Muscle Stimulator FamilyRs Medical · 2002
  • K000114RS-4M+Muscle StimulatorRs Medical · 2000

Recent decisions in NYN

The NYN category page

  • K142236BioniCare Hand SystemVision Quest Industries, Inc. · 2015
  • K111557X-ForceSeven Seas Distribtion and Manufacturing, LLC · 2011
  • K073386Joint Stim, Model 1000Pain Management Technologies · 2008
  • K052625Bionicare Stimulator System, Model Bio-1000Bionicare Medical Technologies, Inc. · 2005
  • K030332Modification to Bionicare Stimulator System, Model Bio-1000Bionicare Medical Technologies, Inc. · 2003

https://510kreport.com/device/K062325 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062325: RS-4I Muscle Stimulator Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062325

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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