Data / Medical devices / United States / RS Medical

RS Medical: FDA-registered device maker in Vancouver, WA, United States, 2 510(k) clearances

Name: RS Medical FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

RS Medical is registered with the FDA (registration 1644243) in Vancouver, WA, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 19, 2012. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1644243
FEI number: 1000117825
Address: 14101 Se 1st St, Vancouver, WA, United States, 98684
Owner or operator: RS MEDICAL (9001699)
Roles: Manufacturer
First device listed: October 24, 2008
Registered through: 2026
Brand names listed: Pronex Cervical Traction Device, RS--LBG Low Back Garment, RS-4i Plus Sequential Stimulator, RS-4s Stimulator, RS-FBG Full Back Conductive Garment, RS-FBG Full Back Garment, RS-LB Low Back Conductive Garment

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Traction, Non-Powered	HST	1	Manufacturer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Manufacturer	accessdata.fda.gov
Interferential Current Therapy	LIH	2	Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 19, 2012	K112348	RS-4I MUSCLE STIMULATOR	IPF	Substantially Equivalent	Rs Medical	accessdata.fda.gov
June 5, 2009	K090951	RS- LB LOW BACK CONDUCTIVE GARMENT, MODEL RS-LBM, RS-LBL, RS-FBG FULL BACK CONDUCTIVE GARMENT , MODEL RS-FBG	GXY	Substantially Equivalent	Rs Medical	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 17, 2010	55578	Not yet classified	Terminated	The "RS-FBG Full Back Conductive Garment" with electrode attachments for use with interferential and muscle stimulation with a Transcutaneous Electrical Nerve Stimulation device (TENS) and/or muscle stimulator. The RS-FB	Device distributed with labeling and IFU outside of their 510(k) clearance.	accessdata.fda.gov
June 11, 2008	55655	Not yet classified	Terminated	The device is labeled in part: " RS Medical RS-4i Stimulator". The device is sold in a kit that includes a carrying case, connector cables, pads (electrodes), battery charger, patient document, instructional DVD, return	The charge current is leaking through two Diodes, which are supposed to block the reverse current, when the device is warm during the main battery charge operation, it then causes the lithium battery to swell around two years of use and it causes the device to be inoperable.	accessdata.fda.gov

Compare with other makers

Updated January 19, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.