FDA.reportPublic FDA data

TCM Packet Comprehensive Instrument

Primary DI
06959962438014
Brand
TCM Packet Comprehensive Instrument
Company
Hunan Jianyuan Medical Science And Technology Co., Ltd.
Model
HNJY001A
Published
2025-02-28
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
16959962438011PackageGS120In Commercial Distribution
06959962438014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695996243801116959962438011
06959962438014069599624380146959962438014

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
404395380
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06959962439011Pain Relief PatchJYT-A2025-02-28
06959962445012TCM Packet Comprehensive Instrument Composite Magnetic Therapy PouchHNJY001A-012025-03-06
06959962445029TCM Packet Comprehensive Instrument Composite Magnetic Therapy PouchHNJY001A-022025-03-06
06959962445036TCM Packet Comprehensive Instrument Composite Magnetic Therapy PouchHNJY001A-032025-03-06
06959962445043TCM Packet Comprehensive Instrument Composite Magnetic Therapy PouchHNJY001A-042025-03-06
06959962445050TCM Packet Comprehensive Instrument Composite Magnetic Therapy PouchHNJY001A-052025-03-06
06959962445067TCM Packet Comprehensive Instrument Composite Magnetic Therapy PouchHNJY001A-062025-03-06
06959962445074TCM Packet Comprehensive Instrument Composite Magnetic Therapy PouchHNJY001A-072025-03-06
06959962445081TCM Packet Comprehensive Instrument Composite Magnetic Therapy PouchHNJY001A-082025-03-06
06959962445098TCM Packet Comprehensive Instrument Composite Magnetic Therapy PouchHNJY001A-092025-03-06
06959962445104TCM Packet Comprehensive Instrument Composite Magnetic Therapy PouchHNJY001A-102025-03-06
16959962445019Type A Composite Magnetic Therapy PouchJYA012025-03-06
16959962445026Type A Composite Magnetic Therapy PouchJYA022025-03-06
16959962445033Type A Composite Magnetic Therapy PouchJYA032025-03-06
16959962445040Type A Composite Magnetic Therapy PouchJYA042025-03-06
16959962445057Type A Composite Magnetic Therapy PouchJYA052025-03-06
16959962445064Type A Composite Magnetic Therapy PouchJYA062025-03-06
16959962445071Type A Composite Magnetic Therapy PouchJYA072025-03-06
16959962445088Type A Composite Magnetic Therapy PouchJYA082025-03-06
16959962445095Type A Composite Magnetic Therapy PouchJYA092025-03-06

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