FDA.reportPublic FDA data

Wonder TDP Heat Lamp

Primary DI
00818318028179
Brand
Wonder TDP Heat Lamp
Company
Prime Holly Corporation
Model
L11
Device description
This lamp features a proprietary mineral plate to emit far infrared band
Published
2022-01-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
00818318028179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818318028179008183180281798183180281790818318028179

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
4085739889info@primeholly.com

Regulatory Flags#

DUNS number
080445043
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818318024027Alpha™ Acupuncture NeedlesN1 Type 0.12 x 30 mmNAN1-44102026-09-10
00818318024126Alpha™ Acupuncture NeedlesN1 Type 0.14 x 30 mmNAN1-42102026-09-10
00818318024218Alpha™ Acupuncture NeedlesN1 Type 0.16 x 15 mmNAN1-40052022-01-24
00818318024225Alpha™ Acupuncture NeedlesN1 Type 0.16 x 30 mmNAN1-40102022-01-24
00818318024300Alpha™ Acupuncture NeedlesN1 Type 0.18 x 7 mmNAN1-38032022-01-24
00818318024317Alpha™ Acupuncture NeedlesN1 Type 0.18 x 15 mmNAN1-38052022-01-24
00818318024324Alpha™ Acupuncture NeedlesN1 Type 0.18 x 30 mmNAN1-38102022-01-24
00818318024331Alpha™ Acupuncture NeedlesN1 Type 0.18 x 40 mmNAN1-38152022-01-24
00818318024416Alpha™ Acupuncture NeedlesN1 Type 0.20 x 15 mmNAN1-36052022-01-24
00818318024423Alpha™ Acupuncture NeedlesN1 Type 0.20 x 30 mmNAN1-36102022-01-31
00818318024430Alpha™ Acupuncture NeedlesN1 Type 0.20 x 40 mmNAN1-36152022-01-24
00818318024515Alpha™ Acupuncture NeedlesN1 Type 0.22 x 15 mmNAN1-34052022-01-24
00818318024522Alpha™ Acupuncture NeedlesN1 Type 0.22 x 30 mmNAN1-34102022-01-24
00818318024539Alpha™ Acupuncture NeedlesN1 Type 0.22 x 40 mmNAN1-34152022-01-24
00818318024546Alpha™ Acupuncture NeedlesN1 Type 0.22 x 50 mmNAN1-34202022-01-24
00818318024614Alpha™ Acupuncture NeedlesN1 Type 0.25 x 15 mmNAN1-32052022-01-24
00818318024621Alpha™ Acupuncture NeedlesN1 Type 0.25 x 30 mmNAN1-32102022-01-24
00818318024638Alpha™ Acupuncture NeedlesN1 Type 0.25 x 40 mmNAN1-32152022-01-24
00818318024720Alpha™ Acupuncture NeedlesN1 Type 0.30 x 30 mmNAN1-30102022-01-24
00818318024737Alpha™ Acupuncture NeedlesN1 Type 0.30 x 40 mmNAN1-30152022-01-24

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Primary DI, Brand, Company table
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