FD TENS 2050 OR SLIDE TENS MODEL FD2050— 510(k) K111645

Name: FDA 510(k) clearance K111645
Creator: U.S. Food and Drug Administration
Published: 2011-11-09

Substantially Equivalent

Fuji Dynamics , Ltd.

FDA 510(k) clearance K111645 for FD TENS 2050 OR SLIDE TENS MODEL FD2050, Substantially Equivalent on 2011-11-09. Applicant: Fuji Dynamics , Ltd.. Device class: 2.

Clearance details

Applicant: Fuji Dynamics , Ltd.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2011-06-13
Decision date: 2011-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hong Kong, CN

Download summary PDF View on FDA.gov ↗

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