510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Coolsystems, Inc.

Berkeley, CA, US

Coolsystems, Inc. appears in FDA device records in Berkeley, CA. FDA records list 2 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
1
Registered establishments
0

510(k) clearance history

FDA records hold 2 510(k) clearances for Coolsystems, Inc. in 2007.

Clearances by year, as a table
510(k) clearance decisions for Coolsystems, Inc., by decision year
YearClearances
20072
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K072620GAME READY CLASSIC SYSTEM, MODEL 550550IRPSubstantially Equivalent
K071050GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEMIRPSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-3210-2011Game Ready Professional Therapy System, a cryotherapy device. Intended to treat postsurgical and acute injuries to reduce edema, swelling and pain where indicated.It was discovered that some Game Ready Professional Therapy System units that were to have been quarantined pending final inspection and testing were inadvertently moved to finished goods inventory and shipped.Terminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain