FLEX-TENS— 510(k) K090717

Substantially Equivalent

Emsi

FDA 510(k) clearance K090717 for FLEX-TENS, Substantially Equivalent on 2009-05-08. Applicant: Emsi. Device class: 2.

Clearance details

Applicant: Emsi
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2009-03-18
Decision date: 2009-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alexandria, VA, US

Download summary PDF View on FDA.gov ↗

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K071869 — TENS/IF 142008-03-07

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