FDA.reportPublic FDA data

Mueller Sports Medicine

Primary DI
00074676006802
Brand
Mueller Sports Medicine
Company
Mueller Sports Medicine, Inc.
Model
M4
Catalog number
M4
Device description
M4 Revive Console
Published
2022-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
K190493000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190493000Recovery Pump, 737R (RPX)Mego Afek AC , Ltd.2019-05-15IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290116950044Direct MarkingGS10
00074676006802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
07290116950044072901169500447290116950044
00074676006802000746760068020746760068020074676006802

GMDN Terms#

Term, Definition table
TermDefinition
Sequential venous compression system inflatorAn electrically-powered device intended to be used for the noninvasive treatment and prevention of venous disorders/sequelae. As part of a compression system, the pump provides the connected stocking/sleeve/suit applied to the extremities with the necessary pressure to promote venous blood flow through its sequential inflation and deflation. Also referred to as a pump, it typically consists of a compressor with advanced control/timing mechanism, pressure limiting device, tubing, and connectors. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Degrees Celcius
Storage Environment Temperature-20 Degrees Celsius66 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(608)643-8530Thomas.Hart@muellersportsmed.com

Regulatory Flags#

DUNS number
006426316
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00074676456102Mueller Aircast Ankle Brace Left White456145612022-08-31
00074676456607Mueller Aircast Ankle Brace Right White456645662022-08-31
00074676006925Mueller Sports MedicineM2M22022-08-31
00074676007045Mueller Sports MedicineRG100RG1002022-08-31
00074676007076Mueller Sports MedicineRG200SMRG200SM2022-08-31
00074676007106Mueller Sports MedicineRG200MDRG200MD2022-08-31
00074676007137Mueller Sports MedicineRG200LGRG200LG2022-08-31
00074676006956Mueller Sports MedicineM2RG200SMM2RG200SM2022-08-31
00074676006987Mueller Sports MedicineM2RG200MDM2RG200MD2022-08-31
00074676007014Mueller Sports MedicineM2RG200LGM2RG200LG2022-08-31
00074676007168Mueller Sports MedicineRG500RG5002022-08-31
00074676007199Mueller Sports MedicineRG400RG5002022-08-31
00074676007229Mueller Sports MedicineRG300RG4002022-08-31
00074676191218Mueller Nasal Sponges1912011912012022-08-31
00074676191225Mueller Nasal Sponges1912021912022022-08-31
00074676912219Mueller Nasal Plugs1912211912212022-08-31
00074676235813MUELLER KINSIOLOGY EASY FIT PRE-CUT NECK23581235812022-10-15
00074676235820MUELLER KINSIOLOGY EASY FIT PRE-CUT ARCH23582235822022-10-15
00074676235837MUELLER KINESIOLOGY EASY FIT PRE-CUT CALF/ANKLE TAPE23583235832022-10-15
00074676235844MUELLER KINESIOLOGY EASY FIT PRE-CUT BK23584235842022-10-15

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