COOLSYSTEMS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
29547773003186150COOLSYSTEMS, INC.1N2020-04-251800 Sutter St Ste 500 Concord CA US 94520
30097615943009761594COOLSYSTEMS, INC.1N2020-04-255165 Commercial Cir Ste B Concord CA US 94520

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
578061716368881K171685Med4 EliteIRP2017-09-29
1450061716368881K171685Med4 EliteIRP2017-09-29
1450061023224601K072620GAME READY CLASSIC SYSTEM, MODEL 550550IRP2007-10-31
578061023224601K072620GAME READY CLASSIC SYSTEM, MODEL 550550IRP2007-10-31
578061698177481K071050GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEMIRP2007-06-29
1450061698177481K071050GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEMIRP2007-06-29
578061913196690
1450061913196690
578062038225571
1450062038225571

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IRP62017-09-29

PMN#