Movement and Compressions System (MAC)

Basic Information

• Brand Name: Movement and Compressions System (MAC)
• Primary DI: B547RF14100
• Version / Model: H
• Catalog Number: RF1410
• Company Name: Recovery Force, LLC
• Labeler DUNS: 079413560
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-05
• Public Version: 7
• Public Version Date: 2023-01-19
• Public Version Status: Update
• Public Device Record Key: 545bf62a-b8a9-4641-af5b-b11fef8c1a9b

Device Description

MAC Controller

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JOW	Sleeve, Limb, Compressible	Cardiovascular	870.5800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10969	Intermittent venous compression system	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B547RF14100	HIBCC
Package	B547RF144020	HIBCC	Kit	2	In Commercial Distribution
Package	B547RF144021	HIBCC	Kit	2	In Commercial Distribution
Package	B547RF144022	HIBCC	Kit	2	In Commercial Distribution
Package	B547RF1440230	HIBCC	Kit	2	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K203052	000

Device Sizes

Type	Value	Unit	Text
Length	136	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -25 – 70 Degrees Celsius