FDA.reportPublic FDA data

Joovv Solo

Primary DI
10855501008010
Brand
Joovv Solo
Company
JOOVV, INC.
Model
EA-150660850
Device description
The Joovv Solo is a red/infrared LED heating device for therapeutic pain relief.
Published
2019-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

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
10855501008010PackageGS12In Commercial Distribution
00855501008013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085550100801010855501008010
00855501008013008555010080138555010080130855501008013

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

Contacts#

Phone, Email table
PhoneEmail
844-465-6688help@joovv.com

Regulatory Flags#

DUNS number
104893063
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855501008617Joovv CloudPT500-F00462025-11-18
00855501008013Joovv SoloEA-1506608502019-11-12
00855501008228Joovv Go NIREA-0128500002019-11-12
00855501008006Joovv MiniEA-0606608502019-11-12
00855501008266Joovv Solo 3.0PT500-F04862021-07-01
10855501008263Joovv Solo 3.0PT500-F04862021-07-01
00855501008273Joovv Mini 3.0PT500-F04872021-07-01
00855501008280Joovv Go 2.0PT500-F04882021-07-01
00855501008211Joovv Go RedEA-0126600002019-11-12
10855501008218Joovv Go RedEA-0126600002019-11-12
10855501008225Joovv Go NIREA-0128500002019-11-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860179001013FUSION PBM Plus LightDentlight Inc.ILY2026-05-27
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B317KLGEHUF0GIROELTECH KLASER SRLILY2026-05-27
B317KLGUHUF0GIROELTECH KLASER SRLILY2026-05-27
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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
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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
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
08906172600081Theraray LIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITEDILY2025-10-10
00810071230509RegenalaseIPG Medical CorporationILY2025-06-09
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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
16978368600037 LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2025-06-05