510(k) Report

FDA applicant

Diamond Systems USA, Inc.

East Rutherford, NJ1 decision2005–20050 recalls

FDA records 1 decision for Diamond Systems USA, Inc. (East Rutherford, NJ) in 2005: 1 510(k) clearance. All are in product code IPF (Stimulator, Muscle, Powered). 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 Diamond Systems USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Diamond Systems USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Diamond Systems USA, 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?

  • IPFStimulator, Muscle, Powered1decision

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?

  • K041390Diamond MedistimDiamond Systems USA, Inc. · 2005

The one decision as Diamond Systems USA, Inc. →

Other applicant names beginning “Diamond”

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

Diamond Diagnostics, Inc. 26Diamond Medical, Inc. 6Diamond Sensor Systems 3Diamond Medical Equipment, Inc. 3Diamond Shamrock Corp. 2Diamond Electro-Tech, Inc. 1Diamond Orthopedic, LLC 1Diamond Rotary and Carbide Intl. 1Diamond Age Systems, Inc. 1Diamond General Development Corp. 1Diamond Orthotic Laboratory 1Diamond Mark International Co., Ltd. 1