510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192234Substantially Equivalent

ActiPatch

Bioelectronics Corporation, Frederick MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192234 is the FDA 510(k) clearance record for ActiPatch, a class II device, cleared for Bioelectronics Corporation on under FDA product code PQY (Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain). FDA's definition for product code PQY reads: "Nonthermal pulsed electromagnetic energy intended for over-the-counter use for the treatment of pain". FDA records list 3 510(k) clearances for Bioelectronics Corporation, from to . As of , FDA records show no recalls naming K192234.

Clearance record

Decision date
Received
(165 days to decision)
Product code
PQY Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Regulation
21 CFR 890.5290
Device class
Class II
Review panel
Physical Medicine
Applicant
Bioelectronics Corporation 4539 Metropolitan Ct., Frederick MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PQY

Trailing 12 months

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

FDA records show no clearances under product code PQY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PQY, 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