FDA.reportPublic FDA data

Anodyne Therapy

Primary DI
00859101006035
Brand
Anodyne Therapy
Company
ANODYNE THERAPY, L.L.C.
Model
480
Published
2016-09-24
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K931261000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K931261000SPECTROPAD SYSTEMSmi1994-03-31ILY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859101006035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859101006035008591010060358591010060350859101006035

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
148751568
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859101006103ANODYNE THERAPY,LLC120-2 LARGE THERAPY PADS2021-03-19
00859101006004Anodyne Therapy1202016-09-24
00859101006011Anodyne Therapy120 Recertified2016-09-24
00859101006028Anodyne Therapy120 Professional2016-09-24
00859101006042Anodyne Therapy480 Recertified2016-09-24
00859101006059Anodyne Therapy3002016-09-24
00859101006066Anodyne TherapyRally Back2016-09-24
00859101006097Anodyne Therapy120-24980112017-05-22

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