510(k) Report

FDA applicant

Labeltape Meditect, Inc.

Grand Rapids, MI26 decisions1986–19951 recall

FDA records 26 decisions for Labeltape Meditect, Inc. (Grand Rapids, MI) from 1986 to 1995: 26 510(k) clearances. Most are in product codes DRX (Electrode, Electrocardiograph) and GXY (Electrode, Cutaneous). 1 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, cardiovascular panel, where it files most

How often FDA has decided Labeltape Meditect, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Labeltape Meditect, Inc. since 2007.

Recalls per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Labeltape Meditect, 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?

  • DRXElectrode, Electrocardiograph10decisions
  • GXYElectrode, Cutaneous9decisions
  • KHEReagent, Occult Blood2decisions
  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive1decision
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision
  • DXHTransmitters And Receivers, Electrocardiograph, Telephone1decision

Also: GZJ (1).

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.

  • K915333Electrode Using Promeon RG-60 Series GelLabeltape Meditect, Inc. · 19922cite it
  • K894042Spect.E.N.S. Repositionable, Pin Type, TensLabeltape Meditect, Inc. · 19891cites it

What has FDA decided for it lately?

  • K951328Lmi Medical, Electrode, Electrosurgical, Disposable Dispersive Electrode with CordLabeltape Meditect, Inc. · 1995
  • K915333Electrode Using Promeon RG-60 Series GelLabeltape Meditect, Inc. · 19921 recall
  • K914871Trans Elec Nerve Stim/Muscle Stim Elec W/Poly GelLabeltape Meditect, Inc. · 1991
  • K912979Hemawipe System, the Civilized Test, ModificationLabeltape Meditect, Inc. · 1991
  • K902738Electro Blue Ecg Electrode-Pediatric ClothLabeltape Meditect, Inc. · 1990
  • K902719Spect.E.N.S. Repostion.-E Foam Pin Type Tens ElectLabeltape Meditect, Inc. · 1990
  • K900656Spec T.E.N.S. Prewired Repositionable Tens Elect.Labeltape Meditect, Inc. · 1990
  • K896844Babe-Ease Neonatal Cloth Ecg ElectrodeLabeltape Meditect, Inc. · 1990

All 26 as Labeltape Meditect, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K915333Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, A cutaneous…Feb 9, 2012Class II