FDA.reportPublic FDA data

Painaway

Primary DI
00852556007299
Brand
Painaway
Company
Multi Radiance Medical
Model
PainAway
Catalog number
U800-100
Published
2019-06-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852556007299PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852556007299008525560072998525560072990852556007299

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
Premarket exempt
true
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
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
00852556007107GameDayGameday LaserU300-2002016-09-23

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Primary DI, Brand, Company table
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B347202366020Dr Dennis Gross SkincareLED TECHNOLOGIES INCILY2026-04-23
B347BDRCK0Bedrock BioscienceLED TECHNOLOGIES INCILY2026-04-23
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B108043POEMVMUS00EMVITALBTL INDUSTRIES LIMITEDILY2025-11-19
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G180DIOWAVESTEALTHMAX0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-11-12
G180DIOWAVE50WLS0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-10-31
08906172600074LightdoctorLIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITEDILY2025-10-10
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16978368600013 LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2025-06-05
16978368600020 LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2025-06-05
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