FDA.reportPublic FDA data

MR4

Primary DI
00852556007213
Brand
MR4
Company
Multi Radiance Medical
Model
MR4 LaserStim Emitter G
Catalog number
650-108G
Published
2016-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852556007213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852556007213008525560072138525560072130852556007213

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal infrared phototherapy unit, non-wearableA mains electricity (AC-powered) device intended to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing. It may be available in a variety of forms however it is not intended to be worn on the body.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
826320694
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852556007374SportLaserSportLaser800-3022025-01-16
00852556007381PainCurePainCure800-3012025-01-16
00852556007350GameDayGameday LaserU800-2002023-07-25
00852556007367GameDayGameday LaserU600-2202023-07-25
00852556007008FibroLuxFibroLux600-5012022-11-08
00852556007336PainAwayPainAway600-2002021-09-07
00852556007343PainAwayPainAway Home Care600-2042021-09-07
00852556007305MR5MR5 Activ Pro Laser Shower GU600-500G2020-08-28
00852556007312MR5MR5 Activ Pro GU600-400G2020-08-28
00852556007329MR5MR5 Activ Pro LaserStim GU600-408G2020-08-28
00852556007299PainawayPainAwayU800-1002019-06-03
00852556007015MR4MR4 Laser SystemU6002016-09-23
00852556007022MR4MR4 Super Pulsed Laser Console6002016-09-23
00852556007039MR4MR4 LaserStim Emitter650-1082016-09-23
00852556007046MR4MR4 SE25 Standard Emitter650-1132016-09-23
00852556007053MR4MR4 LaserShower 50 4-D Emitter650-1142016-09-23
00852556007060MR4MR4 LaserShower 50 6-D Emitter650-1162016-09-23
00852556007077MR4MR4 ActivU600-3002016-09-23
00852556007084TerraQuantTQ Solo LaserU800-3002016-09-23
00852556007091PainAwayPainAway PostOp LaserU300-1102016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07090072490000FlexBeamRecharge Health ASILY2026-10-15
06971712725922DOMASHong Qiangxing (Shen Zhen) Electronics LimitedGZJ2026-10-13
00850012528630ILYEO bodyJoylux, Inc.ILY2026-09-29
00850061407221LS Pro SystemsWELLNESS WITHOUT LIMITS LLCILY2026-09-24
06974958310594mitoredlightShenzhen Idea Light LimitedILY2026-09-21
06974958310600mitoredlightShenzhen Idea Light LimitedILY2026-09-21
06974958310617mitoredlightShenzhen Idea Light LimitedILY2026-09-21
06974958310624mitoredlightShenzhen Idea Light LimitedILY2026-09-21
06979994630002CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630019CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630026CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630033CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630040CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
08800190200004OLIZLTBIO Co., Ltd.ILY2026-08-26
06977782490029QuasarMDNingbo Jinhui Photoelectricity Technology Co., LtdILY2026-08-22
06977782490036QuasarMDNingbo Jinhui Photoelectricity Technology Co., LtdILY2026-08-22
B5171301410Energy Flo TDP Heat LampAcu MarketILY2026-08-21
09361725025374BON CHARGELight Tree Ventures Europe B.V.ILY2026-08-11
00850087184007HomedicsFKA DISTRIBUTING CO., LLCILY2026-08-01
00860015688989HomedicsFKA DISTRIBUTING CO., LLCILY2026-08-01
00860015688996HomedicsFKA DISTRIBUTING CO., LLCILY2026-08-01
06971712726417NourishnestHong Qiangxing (Shen Zhen) Electronics LimitedGZJ2026-07-29
08032625829843NerveOTXDOMINO SRLGZJ2026-07-28
00841436126366LED Instrument CoverCIVCO MEDICAL INSTRUMENTS CO., INC.ILY2026-07-27
00810140062833RENPHOJoicom CorporationILY2026-07-24
00810140063113RENPHOJoicom CorporationILY2026-07-24
00810140063120RENPHOJoicom CorporationILY2026-07-24
00850083596002LaserWrapSPECTRA THERAPY, LLCILY2026-07-24
00850083596026LaserWrapSPECTRA THERAPY, LLCILY2026-07-24
00850026680218Aura WellnessAura Wellness, LLCILY2026-07-21