COOLING/HEATING THERAPY DEVICE— 510(k) K921540

Name: FDA 510(k) clearance K921540
Creator: U.S. Food and Drug Administration
Published: 1992-07-21

Substantially Equivalent

Tempacure Home Care

FDA 510(k) clearance K921540 for COOLING/HEATING THERAPY DEVICE, Substantially Equivalent on 1992-07-21. Applicant: Tempacure Home Care. Device class: 2.

Clearance details

Applicant: Tempacure Home Care
Product code: Code ILO
Device class: Class 2
Regulation: 21 CFR 890.5720
Advisory panel: Physical Medicine
Date received: 1992-04-01
Decision date: 1992-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manassas, VA, US

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