Product Code: BWJ FDA class 2 21 CFR 880.5580

Locator, Acupuncture Point

General Hospital

The Locator, Acupuncture Point is a device used to identify specific acupuncture points on the body's surface by detecting differences in skin electrical resistance or other measurable properties at those locations. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is BWJ, regulated under 21 CFR 880.5580 in the General Hospital specialty.

510(k)s
3
FEI Numbers
5
Registration Numbers
5
Unique Applicants
2
Years Active
2

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Basic Information

Product Code
BWJ
Device Class
FDA class 2
Regulation Number
880.5580
Medical Specialty
General Hospital
Review Panel
HO
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 3 510(k) clearances via K numbers.

K Number Device Name
K792529 POINT LOCATOR STIMULATOR
K792501 PLS MINI
K772424 RYUSEI

FEI Numbers

This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.