510(k) Report

FDA applicant

Umeheal, Ltd.

Shenzhen, CN1 decision2019–20190 recalls

FDA records 1 decision for Umeheal, Ltd. (Shenzhen, CN) in 2019: 1 510(k) clearance. All are in product code IPF (Stimulator, Muscle, Powered). Its devices cite 2 predicates, 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, physical medicine panel, where it files most

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

FDA decisions per year

1in 2019

2019: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Umeheal, Ltd. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • IPFStimulator, Muscle, Powered1decision

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 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.

  • K192733RelieforMe TENS/EMS Device Model UPK-GE01Umeheal, Ltd. · 20191cites it

What has FDA decided for it lately?

  • K192733RelieforMe TENS/EMS Device Model UPK-GE01Umeheal, Ltd. · 2019

The one decision as Umeheal, Ltd. →