510(k) Report

FDA applicant

Hwang Sun Enterprise Co., Ltd.

Sound Beach, NY2 decisions2004–20050 recalls

FDA records 2 decisions for Hwang Sun Enterprise Co., Ltd. (Sound Beach, NY) from 2004 to 2005: 2 510(k) clearances. All are in product code IMI (Ultrasonic Diathermy For Use In Applying…). 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 Hwang Sun Enterprise Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hwang Sun Enterprise Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hwang Sun Enterprise Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat2decisions

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K050410Hes Ultrasonic Therapy Appliance, Models HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ)Hwang Sun Enterprise Co., Ltd. · 20051cites it

What has FDA decided for it lately?

  • K050410Hes Ultrasonic Therapy Appliance, Models HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ)Hwang Sun Enterprise Co., Ltd. · 2005
  • K040798Hes Ultrasonic Therapy ApplianceHwang Sun Enterprise Co., Ltd. · 2004

All 2 as Hwang Sun Enterprise Co., Ltd. →