510(k) Report

FDA applicant

Medical Design & Manufacturing Corp.

Westerville, OH10 decisions1981–19920 recalls

FDA records 10 decisions for Medical Design & Manufacturing Corp. (Westerville, OH) from 1981 to 1992: 10 510(k) clearances. Most are in product codes GXY (Electrode, Cutaneous) 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, neurology panel, where it files most

How often FDA has decided Medical Design & Manufacturing Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medical Design & Manufacturing Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medical Design & Manufacturing Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medical Design & Manufacturing Corp.’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?

  • GXYElectrode, Cutaneous3decisions
  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief3decisions
  • GAGStapler, Surgical1decision
  • HCCDevice, Biofeedback1decision
  • KNXCollector, Urine, (And Accessories) For Indwelling Catheter1decision
  • ITQJoint, Knee, External Brace1decision

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.

  • K911366Protector Disposable Tens and Nmes ElectrodeMedical Design & Manufacturing Corp. · 19911cites it

What has FDA decided for it lately?

  • K911911Medical Designs, Inc. Bio-Therapy SystemMedical Design & Manufacturing Corp. · 1992
  • K914384Medical Designs Reusable Carbon Rubber ElectrodeMedical Design & Manufacturing Corp. · 1991
  • K911366Protector Disposable Tens and Nmes ElectrodeMedical Design & Manufacturing Corp. · 1991
  • K902822Medical Designs, Inc., Spectrum II Tens DeviceMedical Design & Manufacturing Corp. · 1990
  • K895604Soft-EZ Reusable Self-Adhering Pigtail ElectrodesMedical Design & Manufacturing Corp. · 1989
  • K880492Intercept T.E.N.S. DeviceMedical Design & Manufacturing Corp. · 1988
  • K834138Hypo SutureMedical Design & Manufacturing Corp. · 1984
  • K821848Assure-Male External Incontince CatheterMedical Design & Manufacturing Corp. · 1982

All 10 as Medical Design & Manufacturing Corp. →