FDA.reportPublic FDA data

Rapid Reboot

Primary DI
B691CU04100MED0
Brand
Rapid Reboot
Company
RAPID REBOOT RECOVERY PRODUCTS LLC
Model
CU-04-100-MED
Device description
Control Unit, medical
Published
2018-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
B691CU04100MED0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sequential venous compression systemA system used for the noninvasive treatment and prevention of venous disorders and sequelae such as oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE). It functions by applying sequential pressure to a patient's legs to promote venous blood flow. It consists of a compression pump, control/timing mechanism, tubing and has pneumatic stockings, sleeves, or a suit with several chambers that inflate and deflate sequentially in a pattern beginning at the foot or ankle and continuing to chambers around the calf and thigh. In some systems, each chamber reaches the same pressure but at different times, while others apply greater pressure distally which gradually diminishes higher up.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080628101
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
SPGEN1Rapid Reboot Recovery ProductsSP-GEN-12022-08-10
B691SPCL011Rapid Reboot Recovery ProductsSP-CL01-12021-07-12
B691SPCL021Rapid Reboot Recovery ProductsSP-CL02-12021-07-12
B691SPCL031Rapid Reboot Recovery ProductsSP-CL03-12021-07-12
B691SPGEN011Rapid Reboot Recovery ProductsSP-GEN01-12021-07-12
B691SPGEN021Rapid Reboot Recovery ProductsSP-GEN02-12021-07-12
B691SPGEN031Rapid Reboot Recovery ProductsSP-GEN03-12021-07-12
B691SPREN011Rapid Reboot Recovery ProductsSP-REN01-12021-07-12
B691SPREN021Rapid Reboot Recovery ProductsSP-REN02-12021-07-12
B691SPREN031Rapid Reboot Recovery ProductsSP-REN03-12021-07-12
B691SPREN1Rapid Reboot Recovery ProductsSP-REN-12021-07-12
B691SPA00Rapid RebootSP-A02019-01-10
B691SPA10Rapid RebootSP-A12019-01-10
B691SPB00Rapid RebootSP-B02019-01-10
B691SPB10Rapid RebootSP-B12019-01-10
B691SPB20Rapid RebootSP-B22019-01-10
B691SPB30Rapid RebootSP-B32019-01-10
B691SPB40Rapid RebootSP-B42019-01-10
B691SPH00Rapid RebootSP-H02019-01-10
B691SPH10Rapid RebootSP-H12019-01-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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