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510(k) Data Aggregation
K Number
K020119Device Name
VECTORSONIC, MODEL VU-200Manufacturer
Date Cleared
2002-07-22
(189 days)
Product Code
Regulation Number
890.5860Type
TraditionalPanel
Physical MedicineReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The indications for use for the interferential therapy are:
- Relaxation of muscle spasm;
- Prevention or retardation of disuse atrophy;
- Increasing local blood flow;
- Muscle re-education;
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
- Maintaining or increasing range of motion.
The indications for use for the ultrasound therapy are:
- Relief or reduction of pain;
- Reduction of muscle spasm;
- Joint contracture; and
- Local increase in circulation.
The indication for use for the combined therapy is:
- Reduction of muscle spasm.
Device Description
Not Found
AI/ML Overview
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, any specific study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details. The document is an FDA 510(k) clearance letter for the Vectorsonic Model VU-200, which outlines its indications for use and regulatory classification, but does not contain the detailed study information you've requested.
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