ELBOW CPM ORTHOSIS— 510(k) K925043

Substantially Equivalent

Electrobionics Corp.

FDA 510(k) clearance K925043 for ELBOW CPM ORTHOSIS, Substantially Equivalent on 1993-02-12. Applicant: Electrobionics Corp.. Device class: 1.

Clearance details

Applicant: Electrobionics Corp.
Product code: Code BXB
Device class: Class 1
Regulation: 21 CFR 890.5380
Advisory panel: Physical Medicine
Date received: 1992-10-05
Decision date: 1993-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ankeny, IA, 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.