FDA.reportPublic FDA data

HWATO TDP Heat Lamp

Primary DI
06901452000003
Brand
HWATO TDP Heat Lamp
Company
Suzhou Medical Appliance Factory
Model
TDP11-DL
Device description
HWATO TDP Heat Lamp is an infrared lamp that emits the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, to temporarily increase local blood circulation, and to temporarily relieve minor muscle and joint pain and stiffness. The lamps may also help to relieve minor pain associated with muscle spasms, minor sprains and strains, and minor muscular back pain. TDP11-DL represents a type of TDP heat lamp upright with single head, digital timer and big plate.
Published
2017-04-05
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
K063568000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063568000HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XLSuzhou Medical Appliance Factory2007-03-22ILY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06901452000003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06901452000003069014520000036901452000003

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight9Kilogram

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
653739474
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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16901452648196HWATO Yuezhen - ACA COMFORT NEEDLE0.16X132025-05-08
06901452648199HWATO Yuezhen - ACA COMFORT NEEDLE0.16X132025-05-08
06901452000010HWATO TDP Heat Lamp TDP12-XL2017-04-05
06901452000058HWATO TDP Heat LampTDP22-XL2017-04-05
16901452600330HWATO Yuezhen0.20 x 252017-01-26
16901452600569HWATO Yuezhen0.22 x 402017-01-26
16901452648073HWATO Yuezhen - ACA COMFORT NEEDLE0.25X252017-05-18
16901452648080HWATO Yuezhen - ACA COMFORT NEEDLE0.30X252017-05-18
16901452648097HWATO Yuezhen - ACA COMFORT NEEDLE0.20X402017-05-18
16901452648103HWATO Yuezhen - ACA COMFORT NEEDLE0.22X402017-05-18
16901452648110HWATO Yuezhen - ACA COMFORT NEEDLE0.25X402017-05-18
16901452648127HWATO Yuezhen - ACA COMFORT NEEDLE0.30X402017-05-18
16901452648134HWATO Yuezhen - ACA COMFORT NEEDLE0.20X502017-05-18
16901452648141HWATO Yuezhen - ACA COMFORT NEEDLE0.22X502017-05-18
16901452648158HWATO Yuezhen - ACA COMFORT NEEDLE0.25X502017-05-18
16901452648165HWATO Yuezhen - ACA COMFORT NEEDLE0.30X502017-05-18
16901452648172HWATO Yuezhen - ACA COMFORT NEEDLE0.25X132019-08-15
16901452648189HWATO Yuezhen - ACA COMFORT NEEDLE0.30X752021-09-03

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