Z-2093-2010

The "RS-FBG Full Back Conductive Garment" with electrode attachments for use with interferential and muscle...

Name: Z-2093-2010 The "RS-FBG Full Back Conductive Garment" with electrode attachments for use with interferential and muscle...
Creator: International Rehabilitative Sciences, Inc.
Published: 2010-05-17
License: https://open.fda.gov/license/

RS Medical / initiated 2010-05-17 / Terminated / root cause: labeling and UDI

FDA source

International Rehabilitative Sciences, Inc. began a recall of The "RS-FBG Full Back Conductive Garment" with electrode attachments for use with interferential and muscle stimulation with a Transcutaneous Electrical Nerve... on 2010-05-17. The reason FDA records is "Device distributed with labeling and IFU outside of their 510(k) clearance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2093-2010
Status: Terminated
Initiated: 2010-05-17
Posted: 2015-06-26
Terminated: 2012-08-15
Recalling firm: RS Medical
Product: 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.
Product code: GXY Electrode, Cutaneous
Reason for recall: Device distributed with labeling and IFU outside of their 510(k) clearance.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The firm, RS Medical, mailed "URGENT NOTICE OF VOLUNTARY CORRECTIVE ACTION" letters dated May 14, 2010, to customers on May 17, 2010 and letters to physicians/consignees on May 19, 2010. The letters included an updated RS-FBG Operation Manual and stated what the update covered; i.e. that the device is indicated for use on the "middle and upper back". The customers were ask to please read your new manual and replace your original RS-FBG Full Back Conductive Garment Operation Manual with this updated version and discard your old RS-FBG Garment Operation Manual. RS Medical stated that your RS-FBG Garment is not affected by this Corrective Action, only the Operation Manual. RS Medical informed the customers that you may continue to use the RS-FBG Full Back Garment with your RS Medical Stimulator as prescribed by your healthcare provider. If you have any questions or concerns, please call our Toll Free Customer Service number at 1-866-417-1293, email us at [email protected] or visit our special web page at www.rsmedical.com/rsfbginfo.
Quantity in commerce: 108134 units, 81,939 subject to recall
Distribution: Nationwide distribution.
Product codes and lots: ************All serial numbers from "GA133809" and lower. Code Breakdown: "GA" specific for Full Back Garments; "133809" is a six digit sequential number as devices are manufactured.

Product code GXY

K090951Class IIRs- Lb Low Back Conductive Garment, Model Rs-Lbm, Rs-Lbl, Rs-Fbg Full Back Conductive Garment , Model Rs-FbgRs Medical / cleared 2009-06-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)