FDA.reportPublic FDA data

RS-LBG Low Back Garment

Primary DI
00850814007050
Brand
RS-LBG Low Back Garment
Company
R S Medical
Model
959-0051-00
Device description
RS-LBG Low Back Garment System, RS-4i Plus Pin Cable Set and treatment electrodes
Published
2018-09-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090951000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090951000RS- LB LOW BACK CONDUCTIVE GARMENT, MODEL RS-LBM, RS-LBL, RS-FBG FULL BACK CONDUCTIVE GARMENT , MODEL RS-FBGRs Medical2009-06-05GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850814007050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850814007050008508140070508508140070500850814007050

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrodeA non-sterile electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation, cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-935-7763cservice@rsmedical.com

Regulatory Flags#

DUNS number
625133228
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850814007197RS-SG-O Shoulder Garment Only959-0058-002024-02-06
00850814007203RS-LBG-O Low Back Garment Only959-0057-002024-02-06
00850814007210RS-FBG-O Full Back Garment Only959-0056-002024-02-06
00850814007166RS-4s Muscle Stimulator System950-0062-002022-09-14
00850814007180RS-4s Muscle Stimulator System (R)960-0101-002022-09-14
00850814007043RS-4i Plus Sequential Stimulator Kit (R)960-0100-002020-03-04
00850814007012RS-4i Plus Sequential Stimulator Kit950-0056-002018-09-04
00850814007142RS-CLBG Conductive Low Back Garment959-0053-002022-09-14
00850814007159RS-CFBG Conductive Full Back Garment959-0052-002022-09-14
00850814007173RS-SG Shoulder Garment959-0054-002022-09-14
00850814007005RS-LB Low Back Conductive Garment959-0036-002018-09-04
00850814007029RS-FBG Full Back Conductive Garment959-0032-002018-09-04
00850814007036RS-FBG Full Back Garment959-0050-002018-09-04
00850814007074RS Medical180-0005-002017-02-09
00850814007081RS Medical180-0008-002017-02-13
00850814007098RS Medical180-0009-002017-02-09
00850814007104RS Medical180-0010-002017-02-09
00850814007111RS Medical180-0011-002017-02-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08682250582035Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-10-27
08682250582042Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-10-27
08682250582059Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-10-27
10816312029427Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXY2026-10-27
00817717023105SENSADERMVision Quest Industries IncorporatedGXY2026-10-23
00817717023112SENSADERMVision Quest Industries IncorporatedGXY2026-10-23
00817717023129SENSADERM BLUEVision Quest Industries IncorporatedGXY2026-10-23
00817717023136SENSADERMVision Quest Industries IncorporatedGXY2026-10-23
00851913006296UltraStim Wire FoamAXELGAARD MANUFACTURING CO., LTD.GXY2026-10-21
00382830063821NatusXLTEKGXY2026-10-15
00382830063838NatusXLTEKGXY2026-10-15
00382830063845NatusXLTEKGXY2026-10-15
00382830063852NatusXLTEKGXY2026-10-15
00382830063869NatusXLTEKGXY2026-10-15
00382830063876NatusXLTEKGXY2026-10-15
00382830063883NatusXLTEKGXY2026-10-15
00382830063890NatusXLTEKGXY2026-10-15
00382830063906NatusXLTEKGXY2026-10-15
00382830063913NatusXLTEKGXY2026-10-15
00382830063920NatusXLTEKGXY2026-10-15
00382830063937NatusXLTEKGXY2026-10-15
06973602731105Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
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06973602731129Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
00850080988718AUVONUAN HEALTHCARE LIMITEDGXY2026-10-08
00810200390265KSK.S. CHOI, CORPORATIONGXY2026-09-22
00810200390272AcuZoneK.S. CHOI, CORPORATIONGXY2026-09-22
00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.GXY2026-09-04
08720791379131EZ1020Technomed Engineering B.V.GXY2026-08-07