510(k) Report

FDA applicant

Henley Healthcare, Inc.

Sugar Land, TX2 decisions2000–20020 recalls

FDA records 2 decisions for Henley Healthcare, Inc. (Sugar Land, TX) from 2000 to 2002: 2 510(k) clearances. Most are in product codes IMI (Ultrasonic Diathermy For Use In Applying…) and GZJ (Stimulator, Nerve, Transcutaneous, For Pain…). 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 Henley Healthcare, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Henley Healthcare, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Henley Healthcare, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Henley Healthcare, Inc.’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?

  • IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat1decision
  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief1decision

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.

  • K003744Enraf-Nonius Endomed 182 SystemHenley Healthcare, Inc. · 20021cites it

What has FDA decided for it lately?

  • K003744Enraf-Nonius Endomed 182 SystemHenley Healthcare, Inc. · 2002
  • K000084Enraf-Nonius Sonopuls 190 SystemHenley Healthcare, Inc. · 2000

All 2 as Henley Healthcare, Inc. →

Other applicant names beginning “Henley”

FDA records each applicant name separately; these may or may not be the same firm.

Henley Intl. 44Henley Board, Inc. 1