FDA.reportPublic FDA data

Energy Flo TDP Heat Lamp

Primary DI
B5171301410
Brand
Energy Flo TDP Heat Lamp
Company
Acu Market
Model
TDP-11DL
Catalog number
130141
Device description
The Energy Flo TDP Heat Lamp (model TDP-11DL) is an infrared lamp that emits energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, temporarily increasing local blood circulation, and temporarily relieving minor muscle and joint pain and stiffness, including minor pain associated with muscle spasms, minor sprains and strains, and minor muscular back pain. The TDP-11DL is a TDP heat lamp with a large head and digital timer.
Published
2026-08-21
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

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
B5171301410PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal infrared phototherapy unit, non-wearableAn electrically-powered device intended for use in the home or clinical setting 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight0

Regulatory Flags#

DUNS number
150890841
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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

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B517100391010Energy Flo J-Type Acupuncture NeedlesCE-03 0.25 X 75MM WITH TUBE2023-06-07
B5171003920Energy Flo J-Type Acupuncture NeedlesCE-03 0.30 X 75MM WITH TUBE2023-06-07
B517100392010Energy Flo J-Type Acupuncture NeedlesCE-03 0.30 X 75MM WITH TUBE2023-06-07
B5171004030Energy Flo J-Type Acupuncture NeedlesCE-03 0.30 X 40MM WITH TUBE2023-06-07
B517100403010Energy Flo J-Type Acupuncture NeedlesCE-03 0.30 X 40MM WITH TUBE2023-06-07
B5171004950Peace Classic Acupuncture NeedlesCES-08 (30) X 4 WITH TUBE2023-06-07
B5171005300Energy Flo J-Type Acupuncture NeedlesCE-03 0.12 X 15MM WITH TUBE2023-06-07

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