510(k) Report

FDA applicant

Salton, Inc.

Washington, DC2 decisions2001–20030 recalls

FDA records 2 decisions for Salton, Inc. (Washington, DC) from 2001 to 2003: 2 510(k) clearances. Most are in product codes NFO (Stimulator, Transcutaneous Electrical…) and IRP (Massager, Powered Inflatable Tube). 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 Salton, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Salton, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Salton, 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?

  • NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes1decision
  • IRPMassager, Powered Inflatable Tube1decision

Who builds on its devices?

Later devices cite its devices 13 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.

  • K030437Relaxor Perfect Touch Air Massaging SystemSalton, Inc. · 20037cite it
  • K011935Rejuvenique Model #RJV10Salton, Inc. · 20016cite it

What has FDA decided for it lately?

  • K030437Relaxor Perfect Touch Air Massaging SystemSalton, Inc. · 2003
  • K011935Rejuvenique Model #RJV10Salton, Inc. · 2001

All 2 as Salton, Inc. →