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510(k) Data Aggregation
K Number
K030410Device Name
ACCOUSONIC PLUS, MODEL AP-170Manufacturer
Date Cleared
2003-02-20
(13 days)
Product Code
Regulation Number
890.5300Type
SpecialPanel
Physical MedicineReference & Predicate Devices
N/A
Why did this record match?
Device Name :
ACCOUSONIC PLUS, MODEL AP-170
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The indications for use are:
- Relief or reduction of pain;
- Reduction of muscle spasm;
- Joint contracture; and
- Local increase in circulation.
Device Description
Not Found
AI/ML Overview
The provided document is a 510(k) premarket notification letter from the FDA for a device named "AP170 Accusonic Plus," an Ultrasonic Diathermy device. It is a regulatory approval document and does not contain information about the acceptance criteria, study details, or performance metrics of the device as related to its efficacy or safety.
Therefore, I cannot provide the requested information from this document. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements the manufacturer must adhere to.
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