FDA.reportPublic FDA data

Diowave

Primary DI
G180DIOWAVESTEALTHMAX0
Brand
Diowave
Company
TECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.
Model
Diowave Stealth Max DSM
Published
2025-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
G180DIOWAVESTEALTHMAX0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal infrared phototherapy unit, non-wearableAn electrically-powered device intended for use in the home or clinical setting 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.

Regulatory Flags#

DUNS number
019448301
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G180DIOWAVESTEALTHLIT0DiowaveDiowave Stealth Lite DSL 2025-11-12
G180DIOWAVE100WLS0Diowave100WLS2025-11-07
G180DIOWAVE250WLS0Diowave250WLS2025-11-07
G180DIOWAVE50WLS0Diowave50WLS2025-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G710L240Velara Lounge 24SUNSHINE USA, LLCILY2026-05-15
G710A480Velara Ascend 48SUNSHINE USA, LLCILY2026-05-11
G710E320Velara Elite 32SUNSHINE USA, LLCILY2026-05-11
00810140063014RENPHOJoicom CorporationILY2026-05-08
00850001456784MODEL S+ BY SPIRULUX Omm Imports Inc.ILY2026-05-03
00850001456791PRO MED BY JOUVALLE Omm Imports Inc.ILY2026-05-02
B347202366020Dr Dennis Gross SkincareLED TECHNOLOGIES INCILY2026-04-23
B347BDRCK0Bedrock BioscienceLED TECHNOLOGIES INCILY2026-04-23
B347BDRCKED0Bedrock BioscienceLED TECHNOLOGIES INCILY2026-04-23
B347TB202400000TABLED TECHNOLOGIES INCILY2026-04-23
16978368600167LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2026-02-06
16978368600105LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2026-02-06
00811485037210PMDShenzhen Fittop Health Technology Co., Ltd.ILY2026-01-16
B108043POEMVMUS00EMVITALBTL INDUSTRIES LIMITEDILY2025-11-19
B108451APHFAMUS00EMVITAL Hands-Free ApplicatorBTL INDUSTRIES LIMITEDILY2025-11-19
G180DIOWAVESTEALTHLIT0DiowaveTECHNOLOGICAL 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
08906172600081Theraray LIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITEDILY2025-10-10
00810071230509RegenalaseIPG Medical CorporationILY2025-06-09
00810071230516RegenalaseIPG Medical CorporationILY2025-06-09
00810071230530RegenalaseIPG Medical CorporationILY2025-06-09
16978368600013 LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2025-06-05
16978368600020 LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2025-06-05
16978368600037 LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2025-06-05
16978368600044LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2025-06-05
16978368600051LED Light Therapy Mask - HIME SAMAShenzhen Rainbow Technology Co.,LtdILY2025-06-05
16978368600303 LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2025-06-05
16978368600815 LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2025-06-05
16978368600082LED Light Therapy Mask-GYHShenzhen Rainbow Technology Co.,LtdILY2025-06-05