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510(k) Data Aggregation
K Number
K014208Device Name
SSIR SYSTEM
Manufacturer
Date Cleared
2002-07-02
(193 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
RUSSIAN-AMERICAN TECHNOLOGY ASSOCIATES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SSIR System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for:
- the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm;
- the temporary increase in local circulation; and / or
- the temporary relaxation of muscle.
Device Description
The SSIR System is a modern, safe, and easy-to-use devices, which provide continuous heat therapy. The SSIR System consists of a power supply that houses the electronics and controls and treatment module (Velcro Strap Model) that contain the infrared radiating element. The power supply is manufactured from a plastic material that is used in similar products currently in commercial distribution by various medical device companies. The power supply houses a green LED light to indicate when the unit is active.
The Velcro Strap Model is a treatment module comprised of a silicon diode in a black anodized aluminum housing with attached velcro straos. The area of this module that comes in contact with the treatment site is covered with black cotton feit.
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