510(k) Report

FDA applicant

Rs Medical

Vancouver, WA10 decisions1993–20122 recalls

FDA records 10 decisions for Rs Medical (Vancouver, WA) from 1993 to 2012: 10 510(k) clearances. Most are in product codes IPF (Stimulator, Muscle, Powered) and GXY (Electrode, Cutaneous). Its devices cite 11 predicates, 5 of them its own earlier devices. 2 recalls are linked to its devices.

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

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Rs Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2007: 12009: 12012: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2010

2008: 12010: 1
2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Rs Medical by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IPFStimulator, Muscle, Powered8decisions
  • GXYElectrode, Cutaneous1decision
  • NYNStimulator, Electrical, Transcutaneous, For Arthritis1decision

Whose devices does it build on?

Its devices cite 11 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K000114RS-4M+Muscle StimulatorRs Medical · 20003cite it
  • K032652RS-4I Muscle Stimulator FamilyRs Medical · 20033cite it
  • K953136RS-4MRs Medical · 19952cite it
  • K112348RS-4I Muscle StimulatorRs Medical · 20121cites it

What has FDA decided for it lately?

  • 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
  • K000114RS-4M+Muscle StimulatorRs Medical · 2000
  • K990697RS-4V Muscle StimulatorRs Medical · 1999
  • K953136RS-4MRs Medical · 1995

All 10 as Rs Medical →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K090951The "RS-FBG Full Back Conductive Garment" with electrode attachments for use with…May 17, 2010
  • K032652The device is labeled in part: " RS Medical RS-4i Stimulator". The device is sold in a…Jun 11, 2008