EMPI MODEL GLS 450, TENS— 510(k) K861830

Substantially Equivalent

Empi

FDA 510(k) clearance K861830 for EMPI MODEL GLS 450, TENS, Substantially Equivalent on 1986-07-15. Applicant: Empi. Device class: 2.

Clearance details

Applicant: Empi
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1986-05-13
Decision date: 1986-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, 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.