510(k) Report

FDA applicant

Coolsystems, Inc.

Berkeley, CA2 decisions2007–20071 recall

FDA records 2 decisions for Coolsystems, Inc. (Berkeley, CA) in 2007: 2 510(k) clearances. All are in product code IRP (Massager, Powered Inflatable Tube). Its devices cite 3 predicates, 1 of them its own earlier devices. 1 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 Coolsystems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Coolsystems, Inc.’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?

  • IRPMassager, Powered Inflatable Tube2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 1 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.

  • K072620Game Ready Classic System, Model 550550Coolsystems, Inc. · 20074cite it
  • K071050Game Ready Professional Therapy System, Model 550100, Game Ready Pre-Programmed Professional Therapy SystemCoolsystems, Inc. · 20072cite it

What has FDA decided for it lately?

  • K072620Game Ready Classic System, Model 550550Coolsystems, Inc. · 2007
  • K071050Game Ready Professional Therapy System, Model 550100, Game Ready Pre-Programmed Professional Therapy SystemCoolsystems, Inc. · 20071 recall

All 2 as Coolsystems, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K071050Game Ready Professional Therapy System, a cryotherapy device. Intended to treat…Aug 23, 2011