510(k) Report

FDA applicant

Tyece, Ltd.

Kowloon, HK4 decisions2015–20200 recalls

FDA records 4 decisions for Tyece, Ltd. (Kowloon, HK) from 2015 to 2020: 4 510(k) clearances. Most are in product codes NUH (Stimulator, Nerve, Transcutaneous…) and NGX (Stimulator, Muscle, Powered, For Muscle…). Since 2016 its 510(k)s took a median of 117 days from receipt to decision, against 147 for FDA’s reviews in the same codes and years. Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Tyece Limited”.

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

FIG. A — Illustration, neurology panel, where it files most

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

FDA decisions per year

1in 2020

2015: 12017: 12019: 12020: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Tyece, Ltd. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tyece, Ltd.’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?

  • NUHStimulator, Nerve, Transcutaneous, Over-The-Counter2decisions
  • NGXStimulator, Muscle, Powered, For Muscle Conditioning2decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 117 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 147 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 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.

  • K150386Tyece OTC TENS DeviceTyece, Ltd. · 20153cite it

What has FDA decided for it lately?

  • K200838Tyece OTC TENS ModelTyece Limited · 2020
  • K183454Tyece OTC EMS SystemTyece, Ltd. · 2019
  • K172241Tyece OTC EMS System, Model EM35Tyece, Ltd. · 2017
  • K150386Tyece OTC TENS DeviceTyece, Ltd. · 2015

All 3 as Tyece, Ltd. →The one decision as Tyece Limited →