RS Medical

Vancouver, WA, US

RS MEDICAL appears in FDA device records in Vancouver, WA. FDA records list 10 510(k) clearances between 1993-01-28 and 2012-01-19, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 2 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 10
PMA records: 0
Recall records: 2
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to RS Medical carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

International Rehabilitative Sciences, Inc.recall

510(k) clearance history

FDA records hold 10 510(k) clearances for RS Medical between 1993 and 2012. The busiest year on record is 1993, with 2. The most recent is 2012, with 1.

Clearances by year, as a table

510(k) clearance decisions for RS Medical, by decision year
Year	Clearances
1993	2
1995	1
1999	1
2000	1
2002	1
2003	1
2007	1
2009	1
2012	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K112348	RS-4I MUSCLE STIMULATOR	IPF	Substantially Equivalent	2012-01-19
K090951	RS- LB LOW BACK CONDUCTIVE GARMENT, MODEL RS-LBM, RS-LBL, RS-FBG FULL BACK CONDUCTIVE GARMENT , MODEL RS-FBG	GXY	Substantially Equivalent	2009-06-05
K062325	RS-4I MUSCLE STIMULATOR FAMILY	NYN	Substantially Equivalent	2007-04-13
K032652	RS-4I MUSCLE STIMULATOR FAMILY	IPF	Substantially Equivalent	2003-09-12
K021763	RS2MI MUSCLE STIMULATOR FAMILY	IPF	Substantially Equivalent	2002-06-13
K000114	RS-4M+MUSCLE STIMULATOR	IPF	Substantially Equivalent	2000-08-10
K990697	RS-4V MUSCLE STIMULATOR	IPF	Substantially Equivalent	1999-06-18
K953136	RS-4M	IPF	Substantially Equivalent for Some Indications	1995-11-30
K920389	RS-2 NEUROMUSCULAR STIMULATOR	IPF	Substantially Equivalent	1993-01-28
K920388	RS-1 NEUROMUSCULAR STIMULATOR	IPF	Substantially Equivalent	1993-01-28

Registered establishments

FDA registered establishments for RS Medical, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1644243	1000117825	RS MEDICAL	14101 Se 1st St, VANCOUVER, WA 98684 US	2026	GXY HST IPF LIH

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2093-2010	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-FBG is a prescription device for use with RS Medical Stimulators to facilitate electrode placement and maintenance of electrode positioning for stimulation treatments. The device is sold individually in several variations for size. It is fitted to the patient and an RS Medical employee gives the patient instructions on how to utilize the device with proper electrode placement in conjunction with the respective TENS/muscle stimulator.	Device distributed with labeling and IFU outside of their 510(k) clearance.		2010-05-17	Terminated
Z-0323-2011	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 mail bag, and the operation manual. This device is used with cables and electrodes that are placed on skin in the treatment area, and allow an electrical micro-current to relieve pain. The device requires a prescription from a physician. It is programmed by an RS medical employee (or Account Manager) to the physician's specific treatment plan for each patient. The patient is given instructions on how to utilize the device (proper electrode placement). Powered MUSCLE Stimulation indications for use including: 1) Relax muscle spasm. 2) Prevention or retardation of disuse atrophy. 3) Maintain or increase range of motion. 4) Increase local blood circulation. 5) Re-educate muscle. 6) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. INTERFERENTIAL Stimulation indications for use including: 1) Relieve acute pain. 2) Relieve and manage chronic pain.	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.		2008-06-11	Terminated

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain