FDA.reportPublic FDA data

Homedics

Primary DI
00031262115386
Brand
Homedics
Company
FKA DISTRIBUTING CO., LLC
Model
SR-CMC5SHJ-BK
Device description
Modulair compression systemcalf wrap
Published
2024-08-30
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
IRPMassager, Powered Inflatable Tube
IRTPad, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRPMassager, Powered Inflatable TubePhysical Medicine2
IRTPad, Heating, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00031262115386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00031262115386000312621153860312621153860031262115386

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic massagerAn pneumatically-powered device with a vibrating head mechanism which is typically held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head or pads may be interchangeable with others of different size and shape. It can be used for respiratory and physiotherapy treatment, typically in a hospital or institution, but is also suitable for home-use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
183280973
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860015688927HomedicsTIE-050-BABY2026-05-31
00031262100207HOMEDICSHP-G42AJ2020-08-31
00031262114938HOMEDICSSR-GA800J-WMT2024-06-20
00031262114945HOMEDICS SR-GHD800J-WMT2024-06-20
00031262114952HOMEDICS SR-GKM800J-WMT2024-06-20
00031262111975HOMEDICSSR-GHN800J2024-05-01
00031262111982HOMEDICS SR-GHD800J2024-05-01
00031262112002HOMEDICSSR-GA800J2024-05-01
00031262112026HOMEDICSSR-GEM700J2024-05-01
00031262112088HOMEDICSSR-GKM800J2024-05-01
00031262115874HomedicsSCL-XBC200-BK2025-01-25
00031262115898HomedicsSCL-XBC200-WT2025-01-25
00031262115904HomedicsSCL-BBC200-BK2025-01-25
00031262115911HomedicsSCL-BBC200-WT2025-01-25
00031262115959HomedicsSCL-BBC250-BK2025-01-25
00031262115966HomedicsSCL-BBC250-WT2025-01-25
00031262115997HomedicsSCL-BBC350-BK2025-01-25
00031262116000HomedicsSCL-BBC350-WT2025-01-25
00031262111753HomedicsIFR-95HJ2024-10-31
00031262114518HomedicsIFR-99HJ2024-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00622356691161Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356699631Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356703048Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356704885Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
00622356704953Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
00622356710664Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356710718Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356712200Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
00622356736633Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00840295411637TherabodyTherabody, Inc.IRT2026-06-01
08809040526691AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
08809040526707AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
08809040526714AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
08809040526721AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
08809040526776Air Relax Classic Model AR-1.0 ControlUnit OnlyMaxstar Industrial Co.,Ltd.IRP2025-10-01
08809040526783Air Relax Classic Model AR-1.0 Leg Recovery System-Size 2Maxstar Industrial Co.,Ltd.IRP2025-10-01
08809040526790Air Relax Classic Model AR-1.0 Leg Recovery System-Size 3Maxstar Industrial Co.,Ltd.IRP2025-10-01
08809040526806Air Relax Classic Model AR-1.0 Leg Recovery System-Size 4Maxstar Industrial Co.,Ltd.IRP2025-10-01
08809643652087CERAGEM Master V9CERAGEM Co., Ltd.IRP2025-07-15
08809494000686CERAGEM Master V7CERAGEM Co., Ltd.IRP2025-02-12
08809494000983CERAGEM Master V7CERAGEM Co., Ltd.IRP2025-02-12
08809802644526LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644533LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644540LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644557LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644564LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644571LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644588LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644595LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644601LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20