FDA.reportPublic FDA data

REATHLETE

Primary DI
00850020582464
Brand
REATHLETE
Company
Reathlete LLC
Model
FE-7204B
Published
2024-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IRPMassager, Powered Inflatable Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRPMassager, Powered Inflatable TubePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850020582464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850020582464008500205824648500205824640850020582464

GMDN Terms#

Term, Definition table
TermDefinition
Bed/chair electric massagerA mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118708964
Device count
1
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08809802644885LX9maxDAESUNG MAREF CO.,LTD.IRP2025-11-14
08809802644892LX9maxDAESUNG MAREF CO.,LTD.IRP2025-11-14
08809802644908LX9maxDAESUNG MAREF CO.,LTD.IRP2025-11-14
08809802644915LX9maxDAESUNG MAREF CO.,LTD.IRP2025-11-14
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
08809802644618LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644625LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644632LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644649LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644656LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644663LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20