510(k) Report

FDA applicant

Easywell Biomedicals, Inc.

Hsinchu, TW2 decisions2017–20170 recalls

FDA records 2 decisions for Easywell Biomedicals, Inc. (Hsinchu, TW) in 2017: 2 510(k) clearances. Most are in product codes FLL (Continuous Measurement Thermometer) and NUH (Stimulator, Nerve, Transcutaneous…). Its devices cite 1 predicate, 0 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, general hospital panel, where it files most

How often FDA has decided Easywell Biomedicals, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2017

2017: 2
2017high 2 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

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

Planning a device like Easywell Biomedicals, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FLLContinuous Measurement Thermometer1decision
  • NUHStimulator, Nerve, Transcutaneous, Over-The-Counter1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K163166EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS onlyEasywell Biomedicals, Inc. · 2017
  • K162509Infrared Non-contact Thermometer, Model ACT8100Easywell Biomedicals, Inc. · 2017

All 2 as Easywell Biomedicals, Inc. →