510(k) Report

FDA applicant

138 Medical Supplies, Inc.

Great Neck, NY2 decisions1999–20010 recalls

FDA records 2 decisions for 138 Medical Supplies, Inc. (Great Neck, NY) from 1999 to 2001: 2 510(k) clearances. Most are in product codes IPF (Stimulator, Muscle, Powered) and GZJ (Stimulator, Nerve, Transcutaneous, For Pain…). Its devices cite 1 predicate, 0 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, physical medicine panel, where it files most

How often FDA has decided 138 Medical Supplies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for 138 Medical Supplies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — 138 Medical Supplies, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like 138 Medical Supplies, 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?

  • IPFStimulator, Muscle, Powered1decision
  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K000741Ems Jumper II Dual Channel Neuromuscular Stimulator System, Model E-188138 Medical Supplies, Inc. · 2001
  • K9927091818 Tens Unit138 Medical Supplies, Inc. · 1999

All 2 as 138 Medical Supplies, Inc. →