FDA.reportPublic FDA data

Rapid Reboot Recovery Products

Primary DI
B691SPCL021
Brand
Rapid Reboot Recovery Products
Company
RAPID REBOOT RECOVERY PRODUCTS LLC
Model
SP-CL02-1
Device description
RR CLASSIC Control Unit + Two Attachments
Published
2021-07-12
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182668000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182668000Rapid Reboot Compression Therapy SystemRapid Reboot Recovery Products, LLC2018-12-14IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B691SPCL021PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent 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 intermittently applying pressure to a patient's arms or legs to promote venous blood flow at timed intervals. This is achieved through the cyclical inflation and deflation of a single-chambered stocking, sleeve, or suit applied to the extremities. The system typically consists of a compression pump, control and timing mechanism, tubing, and pneumatic stocking(s) or suit.

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
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
B691CU04100MED0Rapid RebootCU-04-100-MED2018-12-01

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Primary DI, Brand, Company table
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