Compressible Limb Therapy System

Basic Information

• Brand Name: Compressible Limb Therapy System
• Primary DI: 08809315678186
• Version / Model: Lympha-Flow(LF400)
• 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: d766ce1f-fc97-4dbb-8404-c625136cce9d

Device Description

Sequential compression pump only

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: Yes
• Has Lot/Batch Number: No
• 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
Primary	08809315678186	GS1
Package	18809315678190	GS1	BOX	1	In Commercial Distribution
Package	28809315678197	GS1	BOX	4	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K150033	000