Compressible Limb Therapy System

Basic Information

• Brand Name: Compressible Limb Therapy System
• Primary DI: 18809315678367
• Version / Model: LX7(V7)
• Company Name: DAESUNG MAREF CO.,LTD.
• Labeler DUNS: 688817949
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-19
• Public Version: 1
• Public Version Date: 2018-07-20
• Public Version Status: New
• Public Device Record Key: 79c1706e-3107-46a4-bf69-6b3edc2e792a

Device Description

Sequential compression pump with 1 double hose and 1 single 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: 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
Package	28809315678364	GS1	Box	2	In Commercial Distribution
Primary	18809315678367	GS1

Premarket Submissions

Submission Number	Supplement Number
K102320	000