510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K792501Substantially Equivalent

Pls Mini

Staodynamics, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K792501 is the FDA 510(k) clearance record for PLS MINI, a class II device, cleared for Staodynamics, Inc. on under FDA product code BWJ (Locator, Acupuncture Point). FDA records list 14 510(k) clearances for Staodynamics, Inc., from to . As of , FDA records show no recalls naming K792501.

Clearance record

Decision date
Received
(84 days to decision)
Product code
BWJ Locator, Acupuncture Point
Regulation
21 CFR 880.5580
Device class
Class II
Review panel
General Hospital
Applicant
Staodynamics, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code BWJ

Trailing 12 months

FDA records hold no clearances under product code BWJ in the trailing twelve months.

FDA records show no clearances under product code BWJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BWJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260