Locator, Acupuncture Point

Device Code: 2531

Product Code(s): BWJ

Device Classification Information

Device Type ID2531
Device NameLocator, Acupuncture Point
Regulation DescriptionAcupuncture Needle.
Regulation Medical SpecialtyGeneral Hospital
Review PanelGeneral Hospital
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type510(K) Exempt
CFR Regulation Number880.5580 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeBWJ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2531
DeviceLocator, Acupuncture Point
Product CodeBWJ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionAcupuncture Needle.
CFR Regulation Number880.5580 [🔎]
TPLC Last Update: 2019-04-02 20:13:51

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