SPORT-ELEC BODY CONTROL SYSTEM, MODEL 4M— 510(k) K092476

Name: FDA 510(k) clearance K092476
Creator: U.S. Food and Drug Administration
Published: 2010-05-07

Substantially Equivalent

Sport-Elec

FDA 510(k) clearance K092476 for SPORT-ELEC BODY CONTROL SYSTEM, MODEL 4M, Substantially Equivalent on 2010-05-07. Applicant: Sport-Elec. Device class: 2.

Clearance details

Applicant: Sport-Elec
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2009-08-12
Decision date: 2010-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hampton, VA, US

Download summary PDF View on FDA.gov ↗

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