510(k) Report

FDA applicant

Sun-Rain System Corp.

Hsin-Chu City, TW3 decisions2001–20090 recalls

FDA records 3 decisions for Sun-Rain System Corp. (Hsin-Chu City, TW) from 2001 to 2009: 3 510(k) clearances. Most are in product codes IMI (Ultrasonic Diathermy For Use In Applying…) and IPF (Stimulator, Muscle, Powered). Its devices cite 1 predicate, 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 Sun-Rain System Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sun-Rain System Corp. 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
  • IPFStimulator, Muscle, Powered1decision

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K024013Sun-Rain Ultrasonic Therapy, SU-100Sun-Rain System Corp. · 20031cites it

What has FDA decided for it lately?

  • K090542Sun-Rain Ultrasonic Therapy Models, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900Sun-Rain System Corp. · 2009
  • K024013Sun-Rain Ultrasonic Therapy, SU-100Sun-Rain System Corp. · 2003
  • K011913Sun-Tens Palm Type R5/Compact Wireles M2 Ems SeriesSun-Rain System Corp. · 2001

All 3 as Sun-Rain System Corp. →