FDA.reportPublic FDA data

RS-4i Plus Sequential Stimulator Kit (R)

Primary DI
00850814007043
Brand
RS-4i Plus Sequential Stimulator Kit (R)
Company
R S Medical
Model
960-0100-00
Device description
RS-4i Plus Sequential Stimulator with Intersperse, Refurbished. Kit includes RS-4i Plus Interferential Stimulator, treatment cable, rechargeable battery, battery charging dock, AC adapter, and treatment electrodes.
Published
2020-03-04
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
LHISet, I.V. Fluid Transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPFStimulator, Muscle, PoweredPhysical Medicine2
LHISet, I.V. Fluid TransferGeneral Hospital2

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
00850814007043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850814007043008508140070438508140070430850814007043

GMDN Terms#

Term, Definition table
TermDefinition
Interferential electrical stimulation systemAn electrically-powered device assembly designed to stimulate peripheral nerves through the transcutaneous application of two currents of slightly different frequencies (e.g., 4000 and 4100 Hz) that cross-over/interfere, producing a beating frequency (i.e., difference between the frequencies of both stimuli) at the treatment point. It typically consists of an external pulse generator and a set of electrodes placed in position to produce the interference at the desired point. The system is used mainly to relieve/manage intractable pain; some include additional electrodes to provide other types of electrical stimuli or suction for therapeutic massage.

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
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

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