FD TENS 2030, MODEL DFJ24T— 510(k) K052813

Name: FDA 510(k) clearance K052813
Creator: U.S. Food and Drug Administration
Published: 2006-01-25

Substantially Equivalent

Fuji Dynamics Limited

FDA 510(k) clearance K052813 for FD TENS 2030, MODEL DFJ24T, Substantially Equivalent on 2006-01-25. Applicant: Fuji Dynamics Limited. Device class: 2.

Clearance details

Applicant: Fuji Dynamics Limited
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2005-10-04
Decision date: 2006-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kowloon, HK

Download summary PDF View on FDA.gov ↗

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