DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM— 510(k) K060735

Name: FDA 510(k) clearance K060735
Creator: U.S. Food and Drug Administration
Published: 2006-05-26

Substantially Equivalent

Axiom Worldwide, Inc.

FDA 510(k) clearance K060735 for DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM, Substantially Equivalent on 2006-05-26. Applicant: Axiom Worldwide, Inc.. Device class: 2.

Clearance details

Applicant: Axiom Worldwide, Inc.
Product code: Code ITH
Device class: Class 2
Regulation: 21 CFR 890.5900
Advisory panel: Physical Medicine
Date received: 2006-03-20
Decision date: 2006-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

Download summary PDF View on FDA.gov ↗

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