FDA.reportPublic FDA data

RS-4s Muscle Stimulator System (R)

Primary DI
00850814007180
Brand
RS-4s Muscle Stimulator System (R)
Company
R S Medical
Model
960-0101-00
Device description
RS-4s Muscle Stimulator System. Refurbished Kit includes RS-4s Muscle Stimulator, treatment cable, rechargeable battery, battery charging dock, AC adapter, and treatment electrodes.
Published
2022-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IPFStimulator, Muscle, Powered
LIHInterferential Current Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPFStimulator, Muscle, PoweredPhysical Medicine2
LIHInterferential Current TherapyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112348000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112348000RS-4I MUSCLE STIMULATORRs Medical2012-01-19IPF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850814007180PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850814007180008508140071808508140071800850814007180

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered unit intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

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
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
00850814007050RS-LBG Low Back Garment959-0051-002018-09-04
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
G345SL2000CIONICCionic, Inc.IPF2026-06-04
03770018808086actiTENSSUBLIMEDIPF2026-05-27
03770018808093actiTENSSUBLIMEDIPF2026-05-27
03770018808109actiTENSSUBLIMEDIPF2026-05-27
03770018808116actiTENSSUBLIMEDIPF2026-05-27
03770018808253actiTENS MiniSUBLIMEDIPF2026-05-27
03770018808260actiTENS MiniSUBLIMEDIPF2026-05-27
08809308380041Talent-pro Electromagnetic StimulatorREMED Co.,Ltd.IPF2026-05-13
07898966442551IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
07898966442698IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
08032625824480GLOBUSDOMINO SRLLIH2026-02-23
08032625824480GLOBUSDOMINO SRLIPF2026-02-23
00714905117649Fab StimDrive Devilbiss HealthcareIPF2026-02-06
00714905117649Fab StimDrive Devilbiss HealthcareLIH2026-02-06
00714905710024Fab StimDrive Devilbiss HealthcareLIH2026-02-06
00714905710024Fab StimDrive Devilbiss HealthcareIPF2026-02-06
00810140062680RENPHOJoicom CorporationIPF2025-10-20
00810140062697RENPHOJoicom CorporationIPF2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.IPF2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.IPF2025-10-03
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.IPF2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.IPF2025-09-11
00810113683379DualPulse CompactManamed, Inc.IPF2025-09-11
00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.IPF2025-09-11
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.IPF2025-08-21
08885022060018Quantum Mitohormesis (QMT)QUANTUMTX PTE. LTD.IPF2025-07-21
00810188050052L360 Thigh SystemBioness Medical, Inc.IPF2025-07-18
00810188050175L100 Go SystemBioness Medical, Inc.IPF2025-07-18
00810188050441H200 Wireless SystemBioness Medical, Inc.IPF2025-07-18
00810188050076L300 Go SystemBioness Medical, Inc.IPF2025-07-17