FDA.reportPublic FDA data

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
30142748453014274845CoolSystems Inc.1N2020-04-252170 Anntom Drive, Unit 7 Ft Lauderdale FL US 33312

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
578061716368881K171685Med4 EliteIRP2017-09-29
1450061716368881K171685Med4 EliteIRP2017-09-29
578061023224601K072620GAME READY CLASSIC SYSTEM, MODEL 550550IRP2007-10-31
1450061023224601K072620GAME READY CLASSIC SYSTEM, MODEL 550550IRP2007-10-31
2161891023224601K072620GAME 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
2161891698177481K071050GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEMIRP2007-06-29
578061913196690
1450061913196690
578062038225571
1450062038225571
2161892038225571

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IRP82017-09-29

PMN#