510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K192114Substantially Equivalent

Game Ready GRPro 2.1 System

Cool Systems, Inc. (dba Game Ready), Concord CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192114 is the FDA 510(k) clearance record for Game Ready GRPro 2.1 System, a class II device, cleared for Cool Systems, Inc. (Dba Game Ready) on under FDA product code IRP (Massager, Powered Inflatable Tube). FDA records list 2 510(k) clearances for Cool Systems, Inc. (Dba Game Ready), from to . As of , FDA records show no recalls naming K192114.

Clearance record

Decision date
Received
(84 days to decision)
Product code
IRP Massager, Powered Inflatable Tube
Regulation
21 CFR 890.5650
Device class
Class II
Review panel
Physical Medicine
Applicant
Cool Systems, Inc. (Dba Game Ready) 1800 Sutter St., Suite 500, Concord CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IRP

Trailing 12 months
11 clearances under product code IRP in the twelve months to October 2026, April 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code IRP, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20260
April 20263
May 20262
June 20261
July 20262
August 20261
September 20260
October 20260