510(k) Report

FDA applicant

Ormed GmbH

Concord, CA2 decisions1997–19970 recalls

FDA records 2 decisions for Ormed GmbH (Concord, CA) in 1997: 2 510(k) clearances. All are in product code ILO (Pack, Hot Or Cold, Water Circulating). 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 Ormed GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ormed GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ormed GmbH 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?

  • ILOPack, Hot Or Cold, Water Circulating2decisions

Who builds on its devices?

Later devices cite its devices 2 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.

  • K964799Artrotherm Cryotherapy and ThernotherapyOrmed GmbH · 19972cite it

What has FDA decided for it lately?

  • K964354Artocool-S Water Circulating Cold PackOrmed GmbH · 1997
  • K964799Artrotherm Cryotherapy and ThernotherapyOrmed GmbH · 1997

All 2 as Ormed GmbH →

Other applicant names beginning “Ormed”

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

Ormed Mfg., Inc. 23Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE 1