Migun

Basic Information

• Brand Name: Migun
• Primary DI: B344HY7000UM0
• Version / Model: HY7000UM
• Company Name: MIGUN LIFE INC
• Labeler DUNS: 033919008
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 6
• Public Version Date: 2020-08-20
• Public Version Status: Update
• Public Device Record Key: 1df3ec2d-15c4-42f1-bcc1-1ffeb8c3891b

Device Description

Migun HY7000UM is a multi-function physio therapy table used primarily for pain relief and to increase local circulation. It utilizes thermal far infra-red therapeutic heating, therapeutic manual and electric massage, and is approved for relief of muscle and joint pain and stiffness, muscle relaxation, temporary increase in circulation and for temporary arthritis pain relief.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
ISA	Massager, Therapeutic, Electric	Physical Medicine	890.5660	1
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	890.5500	2
JFB	Table, Physical Therapy, Multi Function	Physical Medicine	890.5880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46083	Traction table, line-powered	A mobile, mains electricity (AC-powered) table designed to support a patient and to provide traction for the back muscles and spine (e.g., lumbar, cervical) by a motorized mechanical manipulation of the spine. The table surface may consist of sections that can be raised and lowered to manipulate the curvature of the patient?s spine, or apply a rotational roller mechanism protruding through the table surface to the spine, or employ masts and traction accessories for lumbar and cervical traction in a sitting position. Interchangeable traction devices such as head halters, pelvic belts, traction boots, and a traction unit may be used with this table. It is used in a healthcare facility.	No	Active
35147	Musculoskeletal infrared phototherapy unit, non-wearable	A mains electricity (AC-powered) device intended to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing. It may be available in a variety of forms however it is not intended to be worn on the body.	No	Active
35538	Large-area electric massager	An electrically-powered device designed to provide therapeutic massage to a larger area than hand-held massaging devices. It may utilize vibrating belts or other interchangeable mechanisms that are applied to the body to mechanically stimulate the musculature or provide other physiotherapy treatment. This device is intended for use in healthcare facilities and is not applicable to home therapies.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B344HY7000UM0	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K041200	000