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510(k) Data Aggregation
K Number
K041200Device Name
THERMASSAGE ENEGRY PRODUCT, MODEL HY-7000
Manufacturer
MIGUN MEDICAL INSTRUMENT CO. LTD.
Date Cleared
2004-06-17
(41 days)
Product Code
JFB, ILY, ISA
Regulation Number
890.5880Why did this record match?
Applicant Name (Manufacturer) :
MIGUN MEDICAL INSTRUMENT CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Migun Model HY-7000 Thermassage Energy Product is to provide thermassage therapy by delivering heat and soothing massage. Additionally, the infrared lamps provide topical heating for;
- temporary relief of minor muscle and joint pain, and stiffness o
- the temporary relief of minor joint pain associated with arthritis o
- the temporary increase in local circulation where applied o
- relaxation of muscles O
Device Description
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K Number
K032449Device Name
THERMASSAGE ENERGY PRODUCT, MODEL HY5000
Manufacturer
MIGUN MEDICAL INSTRUMENT CO. LTD.
Date Cleared
2003-10-22
(75 days)
Product Code
JFB, ILY
Regulation Number
890.5880Why did this record match?
Applicant Name (Manufacturer) :
MIGUN MEDICAL INSTRUMENT CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Migun Model HY5000 Thermassage Energy Product is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, the infrared lamps provide topical heating for;
- temporary relief of minor muscle and joint pain, and stiffness o
- the temporary relief of minor joint pain associated with arthritis o
- the temporary increase in local circulation where applied O
- relaxation of muscles o
Device Description
The Migun Model HY5000 Thermassage Energy Product is an electrically powered, motorized, multifunctional physical therapy table. It's intended function and use is to provide patients with muscle relaxation therapy by delivering heat and soothing massage.
The massage function is delivered by way of two (2) independent carriages, which are mounted under a pad of the table torso section. The heat function is delivered by use of ten (10) infrared lights, which are mounted directly to the traversing carriages. Each carriage has five (5) infrared lights. During use, these carriages traverse from lower torso to upper torso and apply light pressure as well as heat to the supine user.
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