BODY COOLER OR COOLVEST OR ALPHA BODY COOLER— 510(k) K891603

Name: FDA 510(k) clearance K891603
Creator: U.S. Food and Drug Administration
Published: 1989-07-25

Substantially Equivalent

Alpha Rehabilitation Products

FDA 510(k) clearance K891603 for BODY COOLER OR COOLVEST OR ALPHA BODY COOLER, Substantially Equivalent on 1989-07-25. Applicant: Alpha Rehabilitation Products. Device class: 2.

Clearance details

Applicant: Alpha Rehabilitation Products
Product code: Code ILO
Device class: Class 2
Regulation: 21 CFR 890.5720
Advisory panel: Physical Medicine
Date received: 1989-03-20
Decision date: 1989-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westminster, CO, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.