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510(k) Data Aggregation
K Number
K992099Device Name
BIO SPA INTELLIGENT
Manufacturer
Date Cleared
2002-01-18
(942 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
STARBENE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
MUSCLE STIMULATION THERAPY DELIVERED BY THE BIO SPA INTELLIGENT DEVICE IS INDICATED FOR THE FOLLOWING USES :
- 1- Relaxation of Muscle Spasm
- 2- Prevention or retardation of disuse atrophy
- 3- Increasing local blood circulation
- 4- Muscle re-education
- 5- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis, and
- 6- Maintaining or increasing range of motion
Device Description
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K Number
K991613Device Name
SW ULTRASOUND, MODELS 331, 311, 333
Manufacturer
Date Cleared
2000-12-08
(578 days)
Product Code
Regulation Number
890.5300Why did this record match?
Applicant Name (Manufacturer) :
STARBENE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SW Ultrasound Line is intended for use in applying therapeutic deep heat for selected medical conditions.
Ultrasound therapy is intended to generate 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 (21 CFR 890.5300)
IS A THERAPEUTICAL ULTRASONIC DIATHERMY DEVICE FOR ION THEFULL LONSE TO APPLY THERAPEUTIC DEEP HEAT FOR SELECTED MEDICAL CONDITIONS.
Device Description
The SW Ultrasound Line is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate 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.
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