Coolsystems Inc

FDA Filings

This page includes the latest FDA filings for Coolsystems Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3014274845
FEI Number3014274845
NameCoolSystems Inc.
Owner & OperatorCOOLSYSTEMS, INC.
Contact Address1800 Sutter Street Suite 500
Concord CA 94520 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2170 Anntom Drive, Unit 7
Ft Lauderdale, FL 33312 US
Establishment TypeManufacture Medical Device

Registration Number3009761594
FEI Number3009761594
NameCOOLSYSTEMS, INC.
Owner & OperatorCOOLSYSTEMS, INC.
Contact Address1800 Sutter Street Suite 500
Concord CA 94520 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address5165 Commercial Cir Ste B
Concord, CA 94520 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

Registration Number2954777
FEI Number3003186150
NameCOOLSYSTEMS, INC.
Owner & OperatorCOOLSYSTEMS, INC.
Contact Address1800 Sutter Street Suite 500
Concord CA 94520 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1800 Sutter St Ste 500
Concord, CA 94520 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

FDA Filings

Device
Company
DeviceDate
COOLSYSTEMS, INC.
Med4 Elite2017-10-03
COOLSYSTEMS, INC.
Med4 Elite2017-10-03
COOLSYSTEMS, INC.
Med4 Elite2017-10-03
COOLSYSTEMS, INC.
Med4 Elite2017-10-03
CoolSystems Inc. [COOLSYSTEMS, INC.]
Game Ready2015-12-22
COOLSYSTEMS, INC.
Game Ready2015-12-22
COOLSYSTEMS, INC.
Game Ready2015-12-22
CoolSystems Inc. [COOLSYSTEMS, INC.]
Game Ready2015-12-22
COOLSYSTEMS, INC.
Game Ready2015-12-22
COOLSYSTEMS, INC.
Game Ready2015-12-22
COOLSYSTEMS, INC.
Kineta Post-Op Knee Brace2013-06-21
COOLSYSTEMS, INC.
Kineta Post-Op Knee Brace2013-06-21
CoolSystems Inc. [COOLSYSTEMS, INC.]
Game Ready Therapy System2007-11-01
COOLSYSTEMS, INC.
Game Ready Therapy System2007-11-01
COOLSYSTEMS, INC.
Game Ready Therapy System2007-11-01
CoolSystems Inc. [COOLSYSTEMS, INC.]
Game Ready Therapy System2007-11-01
COOLSYSTEMS, INC.
Game Ready Therapy System2007-11-01
COOLSYSTEMS, INC.
Game Ready Therapy System2007-11-01
COOLSYSTEMS, INC.
GAME READY CLASSIC SYSTEM, MODEL 5505502007-10-31
COOLSYSTEMS, INC.
GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM2007-06-29
CoolSystems Inc. [COOLSYSTEMS, INC.]
COOLSYSTEMS2000-11-02
COOLSYSTEMS, INC.
COOLSYSTEMS2000-11-02
COOLSYSTEMS, INC.
COOLSYSTEMS2000-11-02

Related Finance Registrations
NCAGE Code3FFQ4COOLSYSTEMS, INC.!DBA GAME READY
CAGE Code3FFQ4COOLSYSTEMS, INC. GAME READY
S.A.M. Registration3FFQ4 [840831411]COOLSYSTEMS, INC. GAME READY
SEC0001101849COOLSYSTEMS INC of CALIFORNIA
SEC0001469436CoolSystems, Inc. of CALIFORNIA
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020072024142Kaohsiung,China (Taiwan) -> Oakland, CaliforniaSLEEVES HS 9021.10.0090170 CTN
2020063030448Hong Kong,Hong Kong -> Oakland, CaliforniaORTHOPEDIC DEVICE1 CRT
2020051422879Ningpo ,China (Mainland) -> Oakland, CaliforniaSMART POWER SUPPLY25 CTN
2020011821190Yantian,China (Mainland) -> Oakland, CaliforniaREMOVABLE FILTER FRAME FLUIDIC CONTROL PANEL ASSY. ENCLOSURE KNOB PO# 007675 HS CODE:392690 THIS SHIPMENT CONTAINS NO SOLID WOOD PACKING MATERIALS.140 CTN
2020011322939Kaohsiung,China (Taiwan) -> Oakland, CaliforniaSLEEVES HS CODE 9021.10359 CTN
2019091641432Kaohsiung,China (Taiwan) -> Oakland, CaliforniaSLEEVES HS CODE9021.10331 CTN
2019091438949Kaohsiung,China (Taiwan) -> Oakland, CaliforniaSLEEVES HS CODE9021.10331 CTN
2019051615666Kaohsiung,China (Taiwan) -> Oakland, CaliforniaSLEEVES330 CTN
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