510(k) Report

FDA applicant

Mantra Intl. (Hk), Ltd.

Chatsworth, CA3 decisions2004–20090 recalls

FDA records 3 decisions for Mantra Intl. (Hk), Ltd. (Chatsworth, CA) from 2004 to 2009: 3 510(k) clearances. Most are in product codes GZJ (Stimulator, Nerve, Transcutaneous, For Pain…) and GXY (Electrode, Cutaneous). Its devices cite 4 predicates, 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, neurology panel, where it files most

How often FDA has decided Mantra Intl. (Hk), Ltd.’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 — Mantra Intl. (Hk), Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Mantra Intl. (Hk), 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?

  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief2decisions
  • GXYElectrode, Cutaneous1decision

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K041520Mantra Tens Model NT3Mantra Intl. (Hk), Ltd. · 20041cites it

What has FDA decided for it lately?

  • K091236Mantra Combo, Model Mecs 320Mantra Intl. (Hk), Ltd. · 2009
  • K041902Mantra ElectrodeMantra Intl. (Hk), Ltd. · 2004
  • K041520Mantra Tens Model NT3Mantra Intl. (Hk), Ltd. · 2004

All 3 as Mantra Intl. (Hk), Ltd. →