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510(k) Data Aggregation
K Number
K092589Device Name
THERMOTEX PLATINUM SYSTEM
Manufacturer
EAS CONSULTING GROUP LLC
Date Cleared
2010-01-28
(157 days)
Product Code
ILY, IRT
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
EAS CONSULTING GROUP LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Thermotex Heat Therapy Systems are indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains and minor muscular back pain; muscular relaxation; and the temporary increase of local circulation where applied.
Device Description
The Thermotex Heat Therapy Systems provide infrared heat to different areas of the patient's body. The Systems consist of an outer application cover with adjustable pads that enclose the infrared heating elements to treat different areas of the body. The pad's covers are fabricated of nylon-cotton blend. Velcro fasteners on the cover allow for adjusting the cover and pads for optimum contact to the patient's body areas.
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