Compressible Limb Therapy System(Lympha-Flow(LF400))

Basic Information

• Brand Name: Compressible Limb Therapy System(Lympha-Flow(LF400))
• Primary DI: 08809315678254
• Version / Model: ACg0459
• Company Name: DAESUNG MAREF CO.,LTD.
• Labeler DUNS: 688817949
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-05
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: cedcca60-92e9-4934-a302-c72327023d10

Device Description

4 Chamber Overlapping leg (Medium X-Wide) sleeve with Hose

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• 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
IRP	Massager, Powered Inflatable Tube	Physical Medicine	890.5650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34489	Pneumatic massager	An pneumatically-powered device with a vibrating head mechanism which is typically held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head or pads may be interchangeable with others of different size and shape. It can be used for respiratory and physiotherapy treatment, typically in a hospital or institution, but is also suitable for home-use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	28809315678258	GS1	Box	20	In Commercial Distribution
Primary	08809315678254	GS1
Package	18809315678251	GS1	Box	10	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K150033	000