FDA.reportPublic FDA data

HealthyLine

Primary DI
B905RWCHPLWPHH2200
Brand
HealthyLine
Company
Imedia Ny, Inc.
Model
RWCHPLWPHH220
Device description
Heating pad, powered
Published
2024-12-31
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
B905RWCHPLWPHH2200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electric pad localized-body heating systemAn assembly of mains electricity (AC-powered) devices designed for the transcutaneous application of heat to a localized body site (e.g., joint, limb) to relieve musculoskeletal pain. It consists of an electric heating pad typically made of synthetic fabric materials, and a hand-held control unit used to regulate and monitor the heat. It is intended for use in the home or a clinical setting.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
048362810
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B905014MJT3220L0HealthyLine014MJT3220L2024-12-31
B905014MJT3220L2200HealthyLine014MJT3220L2202024-12-31
B905014MJT72240HealthyLine014MJT72242024-12-31
B905014MJT7224L0HealthyLine014MJT7224L2024-12-31
B905014MJT7224L2200HealthyLine014MJT7224L2202024-12-31
B90502ABLSTH0HealthyLine02ABLSTH2024-12-31
B90502TAOPLWH0HealthyLine02TAOPLWH2024-12-31
B90506A3618PHP2200HealthyLine06A3618PHP2202024-12-31
B905JET2020PHP0HealthyLineJET2020PHP2024-12-31
B905JET2020PHP2200HealthyLineJET2020PHP2202024-12-31
B905JET4024PHP0HealthyLineJET4024PHP2024-12-31
B905JET6024PHP2200HealthyLineJET6024PHP2202024-12-31
B905JET7224PHP2200HealthyLineJET7224PHP2202024-12-31
B905JET7224PHPVELCRO0HealthyLineJET7224PHPVELCRO2024-12-31
B905JET7428PROPHP0HealthyLineJET7428PROPHP2024-12-31
B905JET7428PROPHP2200HealthyLineJET7428PROPHP2202024-12-31
B905JET7428PROPHPVELCR0HealthyLineJET7428PROPHPVELCR2024-12-31
B905JET8726RELPHP2200HealthyLineJET8726RELPHP2202024-12-31
B905JETCHAIR4018PHP0HealthyLineJETCHAIR4018PHP2024-12-31
B905JETCHAIR4018PHP2200HealthyLineJETCHAIR4018PHP2202024-12-31

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