FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR— 510(k) K113010

Name: FDA 510(k) clearance K113010
Creator: U.S. Food and Drug Administration
Published: 2012-12-21

Substantially Equivalent

Famidoc Technology Co., Ltd.

FDA 510(k) clearance K113010 for FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR, Substantially Equivalent on 2012-12-21. Applicant: Famidoc Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Famidoc Technology Co., Ltd.
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2011-10-11
Decision date: 2012-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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