FDA.reportPublic FDA data

heat it classic Lightning

Primary DI
04262370293086
Brand
heat it classic Lightning
Company
Kamedi GmbH
Model
010_00575-5
Device description
Smartphone add-on for the symptomatic treatment of insect bites with heat.
Published
2024-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IRTPad, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04262370293086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04262370293086042623702930864262370293086

GMDN Terms#

Term, Definition table
TermDefinition
Insect bite/sting hyperthermia deviceA portable, electrically-powered device intended to be used for the external surface treatment of insect bites or stings (e.g., from midges/gnats, mosquitoes, wasps, hornets, horseflies) through the topical application of concentrated heat. The heat (around 50° Celsius) works to minimize or prevent itching, and may prevent subsequent swelling. It may be either a self-contained hand-held unit or an attachment for a smartphone. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature41 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-13 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315161593
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04262370293017heat it pro USB-C010_00577-22024-04-23
04262370293031heat it classic USB-C010_00575-42024-04-23
04262370293062heat it pro Lightning010_00577-32024-04-23
04262370293116heat it for Android00003AN2022-09-13
04262370293123heat it for iPhone00003IN2022-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00041298995043DMID-M-S HOLDINGS, INC.IRT2025-12-30
09413000135374Flowpresso Compression DeviceMEDELLA HEALTH LIMITEDIRT2025-10-16
00041298991960DMID-M-S HOLDINGS, INC.IRT2025-06-12
00031262116291HomedicsHuizhou XINYI Technology Co., LTDIRT2025-02-01
00031262116697HomedicsHuizhou XINYI Technology Co., LTDIRT2025-01-01
00031262116666HomedicsHuizhou XINYI Technology Co., LTDIRT2024-12-31
00031262109507HomedicsHuizhou XINYI Technology Co., LTDIRT2024-11-12
00031262113306HomedicsFKA DISTRIBUTING CO., LLCIRT2024-09-30
00031262115416HomedicsFKA DISTRIBUTING CO., LLCIRT2024-09-30
00031262115379HomedicsFKA DISTRIBUTING CO., LLCIRT2024-08-30
00031262115386HomedicsFKA DISTRIBUTING CO., LLCIRT2024-08-30
00031262115393HomedicsFKA DISTRIBUTING CO., LLCIRT2024-08-30
00031262115423HomedicsFKA DISTRIBUTING CO., LLCIRT2024-08-30
00031262115768HomedicsFKA DISTRIBUTING CO., LLCIRT2024-08-30
00041298991953DMID-M-S HOLDINGS, INC.IRT2024-02-28
B311PETNHTPR0PURE ENRICHMENTBEAR DOWN CONSULTINGIRT2023-12-15
00031262110527HOMEDICSFKA DISTRIBUTING CO., LLCIRT2023-08-21
00031262108739HOMEDICSFKA DISTRIBUTING CO., LLCIRT2023-08-10
00031262110541HOMEDICSFKA DISTRIBUTING CO., LLCIRT2023-08-10
00031262110640HOMEDICSFKA DISTRIBUTING CO., LLCIRT2023-08-10
00041298051312DMID-M-S HOLDINGS, INC.IRT2023-06-06
00041298991489DMID-M-S HOLDINGS, INC.IRT2023-03-17
00041298051336DMID-M-S HOLDINGS, INC.IRT2023-03-14
00011822820240Rite AidRITE AID CORPORATIONIRT2022-10-20
00011822820226Rite AidRITE AID CORPORATIONIRT2022-05-31
00031262101730HOMEDICSHOMEDICS USA, LLCIRT2021-06-01
00031262101556HOMEDICSFKA DISTRIBUTING CO., LLCIRT2021-05-28
16971912180030Walgreens heating padNINGBO BELLA VIE CO., LTDIRT2021-05-11
16971912180016RENPHO heating padNINGBO BELLA VIE CO., LTDIRT2021-03-31
16971912180023Walgreens heating padNINGBO BELLA VIE CO., LTDIRT2021-03-31