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
00818318024430Alpha™ Acupuncture NeedlesN1 Type 0.20 x 40 mmNAN1-36152022-01-24
00818318028162Wonder TDP Heat LampL012022-01-24
00818318028186Wonder Double Head TDP Heat LampL022022-01-21
00818318020029Fine Point Acupuncture NeedleT1 Type 0.12 x 25 mmNFT1-44102025-09-03
00818318020128Fine Point Acupuncture NeedleT1 Type 0.14 x 25 mmNFT1-42102025-09-03
00818318020227Fine Point Acupuncture NeedleT1 Type 0.16 x 25 mmNFT1-40102025-09-03
10818318020026Fine Point Acupuncture NeedleT1 Type 0.12 x 25 mmNFT1-44102025-09-03
10818318020125Fine Point Acupuncture NeedleT1 Type 0.14 x 25 mmNFT1-42102025-09-03
10818318020224Fine Point Acupuncture NeedleT1 Type 0.16 x 25 mmNFT1-40102025-09-03
00818318022115Alpha Acupuncture NeedleT1 Type 0.14 x 15 mmNAT1-42052025-09-02
00818318022214Alpha Acupuncture NeedleT1 Type 0.16 x 15 mmNAT1-40052017-03-15
00818318022221Alpha Acupuncture NeedleT1 Type 0.16 x 30 mmNAT1-40102017-03-15
00818318022313Alpha Acupuncture NeedleT1 Type 0.18 x 15 mmNAT1-38052017-03-15
00818318022320Alpha Acupuncture NeedleT1 Type 0.18 x 30 mmNAT1-38102017-03-15
00818318022412Alpha Acupuncture NeedleT1 Type 0.20 x 15 mmNAT1-36052017-03-15
00818318022429Alpha Acupuncture NeedleT1 Type 0.20 x 30 mmNAT1-36102017-03-15
00818318022436Alpha Acupuncture NeedleT1 Type 0.20 x 40 mmNAT1-36152017-03-15
00818318022443Alpha Acupuncture NeedleT1 Type 0.20 x 50 mmNAT1-36202017-03-14
00818318022528Alpha Acupuncture NeedleT1 Type 0.22 x 30 mmNAT1-34102017-03-15
00818318022535Alpha Acupuncture NeedleT1 Type 0.22 x 40 mmNAT1-34152017-03-15

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