FES ORTHOSIS MODEL NO. 2000— 510(k) K800380

Substantially Equivalent

Empi

FDA 510(k) clearance K800380 for FES ORTHOSIS MODEL NO. 2000, Substantially Equivalent on 1980-03-17. Applicant: Empi. Device class: 2.

Clearance details

Applicant: Empi
Product code: Code GZI
Device class: Class 2
Regulation: 21 CFR 882.5810
Advisory panel: Neurology
Date received: 1980-02-22
Decision date: 1980-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.