Atlas FDA

BWJ

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Locator, Acupuncture Point
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5580
Medical specialty
General Hospital
Adverse events (MAUDE)
2003: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
POINT LOCATOR STIMULATOR (K792529)Staodynamics, Inc.1980-02-26
PLS MINI (K792501)Staodynamics, Inc.1980-02-26
RYUSEI (K772424)Ercona Corp.1978-05-09

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Every clearance here is in the API, with alerts when new ones post.