510(k) Report

FDA applicant

Bioelectronics Corporation

Frederick, MD3 decisions2017–20200 recalls

FDA records 3 decisions for Bioelectronics Corporation (Frederick, MD) from 2017 to 2020: 3 510(k) clearances. Most are in product codes PQY (Nonthermal Shortwave Therapy Device Indicated…) and ILX (Diathermy, Shortwave, For Use Other Than…). Its devices cite 6 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Bioelectronics Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2017: 12019: 12020: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Bioelectronics Corporation by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PQYNonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment…2decisions
  • ILXDiathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat1decision

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K152432ActiPatch (R)Bioelectronics Corporation · 20171cites it

What has FDA decided for it lately?

  • K192234ActiPatchBioelectronics Corporation · 2020
  • K190251RecoveryRxBioelectronics Corporation · 2019
  • K152432ActiPatch (R)Bioelectronics Corporation · 2017

All 3 as Bioelectronics Corporation →