FDA.reportPublic FDA data

Mueller Sports Medicine

Primary DI
00074676007045
Brand
Mueller Sports Medicine
Company
Mueller Sports Medicine, Inc.
Model
RG100
Catalog number
RG100
Device description
REVIVE CALF BOOT GRAY PAIR
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
K163280000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163280000RP Lite 760RMego Afek AC , Ltd.2017-01-27IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00074676007045PrimaryGS10
80074676007041Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00074676007045000746760070450746760070450074676007045
8007467600704180074676007041

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.

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
2
DM exempt
true
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
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
00074676006802Mueller Sports MedicineM4M42022-08-31
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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