FDA product code BWJ: Locator, Acupuncture Point
BWJ is the FDA product code for locator, acupuncture point. It is a Class II device, regulated under 21 CFR 880.5580 and reviewed by the General Hospital panel. FDA has cleared 3 510(k) submissions under BWJ, from 2 different applicants. The average 510(k) review took 99 days (median 84).
Classification
| Field | Value |
|---|---|
| Device name | Locator, Acupuncture Point |
| Device class | Class II |
| Regulation | 21 CFR 880.5580 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BWJ clearance
Top BWJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Staodynamics, Inc. | 2 | 1980-02-26 |
| Ercona Corp. | 1 | 1978-05-09 |
Most recent BWJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K792501 | Staodynamics, Inc. | PLS MINI | 1980-02-26 | 84 |
| K792529 | Staodynamics, Inc. | POINT LOCATOR STIMULATOR | 1980-02-26 | 81 |
| K772424 | Ercona Corp. | RYUSEI | 1978-05-09 | 132 |
Recalls for BWJ devices
openFDA lists no recalls for product code BWJ.
Frequently asked questions
What is FDA product code BWJ?
BWJ is the FDA product code for locator, acupuncture point. It is a Class II device, regulated under 21 CFR 880.5580 and reviewed by the General Hospital panel.
What device class is BWJ?
Class II, regulation 21 CFR 880.5580. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BWJ?
Across 3 cleared submissions the average was 99 days from receipt to decision (median 84).
Which companies have the most BWJ clearances?
Staodynamics, Inc. (2); Ercona Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code BWJ
- Run a recall and safety report across every BWJ manufacturer
- Watch product code BWJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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