THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS)— 510(k) K940858

Name: FDA 510(k) clearance K940858
Creator: U.S. Food and Drug Administration
Published: 1994-07-12

Substantially Equivalent for Some Indications

Innovation Sports, Inc.

FDA 510(k) clearance K940858 for THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS), Substantially Equivalent for Some Indications on 1994-07-12. Applicant: Innovation Sports, Inc.. Device class: 2.

Clearance details

Applicant: Innovation Sports, Inc.
Product code: Code ILO
Device class: Class 2
Regulation: 21 CFR 890.5720
Advisory panel: Physical Medicine
Date received: 1994-02-23
Decision date: 1994-07-12
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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