510(k) Report

FDA applicant

Eco-Med Pharmaceuticals, Inc.

Mississauga, Ontario, CA4 decisions1996–199618 recalls

FDA records 4 decisions for Eco-Med Pharmaceuticals, Inc. (Mississauga, Ontario, CA) in 1996: 4 510(k) clearances. Most are in product codes ITX (Transducer, Ultrasonic, Diagnostic) and GYB (Media, Electroconductive). 18 recalls are linked to its devices, 18 Class I.

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

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

How often FDA has decided Eco-Med Pharmaceuticals, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Eco-Med Pharmaceuticals, Inc. since 2007.

Recalls per year

18in 2021

2021: 18, 18 Class I
2007high 18 (2021) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • ITXTransducer, Ultrasonic, Diagnostic3decisions
  • GYBMedia, Electroconductive1decision

Who builds on its devices?

Later devices cite its devices 4 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.

  • K961757Ecogel 100 Ultrasound GelEco-Med Pharmaceuticals, Inc. · 19964cite it

What has FDA decided for it lately?

  • K962840Ecolotion Transmission and Massage LotionEco-Med Pharmaceuticals, Inc. · 19964 Class I recalls
  • K962681Ecogel 300 Tens GelEco-Med Pharmaceuticals, Inc. · 19961 Class I recall
  • K961757Ecogel 100 Ultrasound GelEco-Med Pharmaceuticals, Inc. · 19962 Class I recalls
  • K955246Ecogel 200 Ultrasound GelEco-Med Pharmaceuticals, Inc. · 199613 Class I recalls

All 4 as Eco-Med Pharmaceuticals, Inc. →

What has been recalled?

18 recalls linked to its devices; the latest:

  • K955246IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L…Oct 14, 2021Class I
  • K955246GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5…Sep 7, 2021Class I
  • K962840Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF…Sep 7, 2021Class I
  • K962840EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description…Aug 27, 2021Class I
  • K955246Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL…Aug 27, 2021Class I
  • K955246Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle…Aug 25, 2021Class I