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510(k) Data Aggregation
K Number
K011669Device Name
BW ACUPUNCTURE NEEDLESManufacturer
Date Cleared
2001-07-09
(40 days)
Product Code
Regulation Number
880.5580Type
TraditionalPanel
General HospitalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The acupuncture needles are devices which are intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Device Description
Not Found
AI/ML Overview
This document is a 510(k) clearance letter from the FDA for "HBW Acupuncture Needles". It does not describe any acceptance criteria or a study proving that a device meets such criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information based on the provided text. The document is an FDA clearance letter, not a clinical study report or a summary of performance data.
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