TENS STIMULATOR, MODELS 2800 AND 3000— 510(k) K102014

Name: FDA 510(k) clearance K102014
Creator: U.S. Food and Drug Administration
Published: 2010-08-31

Substantially Equivalent

Koalaty Products, Inc.

FDA 510(k) clearance K102014 for TENS STIMULATOR, MODELS 2800 AND 3000, Substantially Equivalent on 2010-08-31. Applicant: Koalaty Products, Inc.. Device class: 2.

Clearance details

Applicant: Koalaty Products, Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2010-07-16
Decision date: 2010-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, Guangdong, CN

Download summary PDF View on FDA.gov ↗

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