ELECTRI-COOL(TM) LIQUID-CIRCULAT. THERMAL THERAPY— 510(k) K902269

Clearance details

Applicant

Seabrook Medical Systems, Inc.

Product code

Code ILO

Device class

Class 2

Regulation

21 CFR 890.5720

Advisory panel

Physical Medicine

Date received

1990-05-21

Decision date

1990-06-21

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Cincinnati, OH, US

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• Z-1129-2015 — Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used to provide a patient with local cold therapy by circulating chilled water through the pad that has been positioned on the patient.Class II·Terminated·Cincinnati Sub-Zero Products Inc·20150107

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K902269.