FDA.reportPublic FDA data

Movement and Compressions System (MAC)

Primary DI
B547RF1440221
Brand
Movement and Compressions System (MAC)
Company
Recovery Force Health, LLC
Model
1
Catalog number
RF1440-22
Device description
MAC System Kit, 4 Bariatric Straps, 2 controllers, 1 charging station.
Published
2023-01-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOWSleeve, Limb, Compressible

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOWSleeve, Limb, CompressibleCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203052000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203052000Movement and Compressions System (the MAC System)Recovery Force, LLC2021-03-21JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B547RF1440221PrimaryHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866.604.6458info@recoveryforceusa.com

Regulatory Flags#

DUNS number
105958323
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B547RF14200Movement and Compressions System (MAC)5RF14202021-04-05
B547RF14210Movement and Compressions System (MAC)5RF14212021-04-05
B547RF14220Movement and Compressions System (MAC)4RF14222021-05-07
B547RF1440201Movement and Compressions System (MAC)1RF1440-202023-01-16
B547RF1440211Movement and Compressions System (MAC)1RF1440-212023-01-16
B547RF1440231Movement and Compressions System (MAC)1RF1440-232023-01-16
B547RF14230Movement and Compressions System (MAC)1RF14232022-06-10
B547RF14100Movement and Compressions System (MAC)HRF14102021-04-05
B547RF14300Movement and Compressions System (MAC)BRF14302021-04-05

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