EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101)— 510(k) K070299

Name: FDA 510(k) clearance K070299
Creator: U.S. Food and Drug Administration
Published: 2007-07-16

Substantially Equivalent

Ezfit Technology, Inc.

FDA 510(k) clearance K070299 for EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101), Substantially Equivalent on 2007-07-16. Applicant: Ezfit Technology, Inc.. Device class: 2.

Clearance details

Applicant: Ezfit Technology, Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2007-01-31
Decision date: 2007-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tainan City, TW

Download summary PDF View on FDA.gov ↗

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