FDA.reportPublic FDA data

Homedics

Primary DI
00031262115423
Brand
Homedics
Company
FKA DISTRIBUTING CO., LLC
Model
SR-CMX10JA-BK
Device description
Modulair compression systemuniversal controller
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
00031262115423PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00031262115423000312621154230312621154230031262115423

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
00850087184007HomedicsSPE-RLWS130J2026-08-01
00850087184045HomedicsTENS-150J-CA2026-07-31
00860015688989HomedicsSPE-RLW255J2026-08-01
00860015688996HomedicsSPE-RLW135J2026-08-01
00850087184038HomedicsIFR-571HJ-CA2026-07-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00622356729444Shark™ DePuffi™SharkNinja Operating LLCIRT2026-10-26
00810050289252HYPERICENORMATEC INDUSTRIES LPIRT2026-10-19
00810050289252HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289269HYPERICENORMATEC INDUSTRIES LPIRT2026-10-19
00810050289269HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289276HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289276HYPERICENORMATEC INDUSTRIES LPIRT2026-10-19
00810050289283HYPERICENORMATEC INDUSTRIES LPIRT2026-10-19
00810050289283HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289290HYPERICENORMATEC INDUSTRIES LPIRT2026-10-19
00810050289290HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289306HYPERICENORMATEC INDUSTRIES LPIRT2026-10-19
00810050289306HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
06959557201382Air Compression Therapy DeviceSHENZHEN FUTURE ELECTRONIC CO.,LTDIRP2026-10-15
03858894530502ZT Cube - ZC3ZAMAR MEDICAL d.o.o.IRP2026-10-12
03858894530618ZT CLINICZAMAR MEDICAL d.o.o.IRP2026-10-12
06976331781397AnacondafightwearHuizhou XINYI Technology Co., LTDIRP2026-10-12
06959557201375Air Compression Therapy DeviceSHENZHEN FUTURE ELECTRONIC CO.,LTDIRP2026-10-10
06959557200286Powered Inflatable Tube MassagerSHENZHEN FUTURE ELECTRONIC CO.,LTDIRP2026-09-30
06974000130033HealthpalXiamen Healthpal Electronic Co., Ltd.IRP2026-08-26
00622356753760Shark™ FacialPro Glow™SharkNinja Operating LLCIRT2026-08-17
00622356753937Shark™ FacialPro Glow™SharkNinja Operating LLCIRT2026-08-17
00622356759533Shark™ FacialPro Glow™SharkNinja Operating LLCIRT2026-08-17
00040337006559ThermophoreBattle Creek Equipment Co.IRT2026-08-07
00812120004895Game Ready* SystemAvanos Medical, Inc.IRP2026-07-31
00812120005076Game Ready* Full Leg Boot Wrap, MediumAvanos Medical, Inc.IRP2026-07-31
00812120005113Game Ready* Ankle Wrap, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005120Game Ready* Ankle Wrap, Extra LargeAvanos Medical, Inc.IRP2026-07-31
00812120005137Game Ready* Shoulder Wrap, Medium, RightAvanos Medical, Inc.IRP2026-07-31
00812120005144Game Ready* Shoulder Wrap, Medium, LeftAvanos Medical, Inc.IRP2026-07-31