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510(k) Data Aggregation
K Number
K022626Device Name
MOISTURESTAY (REVLON)Manufacturer
Date Cleared
2002-10-29
(83 days)
Product Code
Regulation Number
890.5110Type
TraditionalPanel
Physical MedicineReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
RAYMOND INDUSTRIAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Useful in symptomatic relief of pain caused by arthritis, bursitis, and chronic joint inflammation.
Relaxes muscles, relieves stiffness and muscle spasm.
Stimulates circulation and for other conditions where heat is indicated.
Device Description
Luxury Paraffin Bath
AI/ML Overview
The provided text is a 510(k) premarket notification letter from the FDA regarding a paraffin bath device. It does not contain any information about acceptance criteria, device performance, studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot provide the requested table and details. The document is solely a regulatory approval letter.
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