FDA.reportPublic FDA data

HealthLight

Primary DI
00858935006013
Brand
HealthLight
Company
HEALTHLIGHT LLC
Model
HL-90R
Catalog number
502001
Device description
90 LED Pad, Infrared Phototherapy Unit
Published
2016-07-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00858935006013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858935006013008589350060138589350060130858935006013

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
224-231-0342cjohl@healthlightllc.com

Regulatory Flags#

DUNS number
080183509
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858935006679HealthLightHL-C2J5020542021-09-20
00858935006686CARELightCL-C2J6020172021-09-20
00858935006655HealthLightHL-KneeR5020522021-07-16
00858935006662CARELightCL-KneeR6020342021-07-16
00858935006617HealthLightHL-T-padR5020462021-03-04
00858935006631CARELightCL-180R-E6020322021-03-03
00858935006648CARELightCL-64R-E6020332021-03-03
00858935006266HealthLightHL-NP5020322020-09-09
00858935006488CARELightCL-264B6020212020-08-12
00858935006495CARELightCL-180T6020222020-08-12
00858935006501CARELightCL-C3602023, 6020302020-08-12
00858935006518CARELightCL-132B6020242020-08-12
00858935006525HealthlightHL-444-S5020362020-08-12
00858935006532HealthLightHL-264B5020372020-08-12
00858935006549HealthLightHL-132B5020402020-08-12
00858935006556HealthLightHL-180T5020412020-08-12
00858935006563HealthlightHL-264B-S5020422020-08-12
00858935006570HealthlightHL-132B-S5020432020-08-12
00858935006587HealthLightHL-180T-S5020442020-08-12
00858935006594HealthLightHL-C25020452020-08-12

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