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510(k) Data Aggregation
K Number
K090542Device Name
SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900
Manufacturer
Date Cleared
2009-10-23
(235 days)
Product Code
Regulation Number
890.5300Why did this record match?
Applicant Name (Manufacturer) :
SUN-RAIN SYSTEM CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SUN-RAIN Ultrasonic Therapy generates deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.
Device Description
Ultrasonic equipment generates high frequency sound waves that are transferred to a specific body area via a round-headed probe. The sound waves travel deep into tissue and create gentle heat. As the probe glides over the skin's surface, sound waves penetrate the skin's surface causing soft tissues to creating deep heat. In turn, the heat induces vasodilatation: drawing blood into the target tissues. The generated deep heat is found to help relieve pain and reduce muscle spasms.
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K Number
K024013Device Name
SUN-RAIN ULTRASONIC THERAPY, SU-100
Manufacturer
Date Cleared
2003-10-31
(331 days)
Product Code
Regulation Number
890.5300Why did this record match?
Applicant Name (Manufacturer) :
SUN-RAIN SYSTEM CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SU-100 generates deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.
Device Description
Not Found
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K Number
K011913Device Name
SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES
Manufacturer
Date Cleared
2001-10-26
(129 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
SUN-RAIN SYSTEM CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
- Specific indications: used to apply an electrical current to electrodes on patient's skin to function as:
Relaxation of muscle spasms;
Prevention or retardation of disuse atrophy
Muscle re-education
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Maintaining or increasing range of motion.
- Clinical settings: The device should only be used under medical supervisions for adjunctive therapy for the treatment of medical diseases and conditions.
Device Description
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