CIRCUL8 Luxe DVT Prevention Device— 510(k) K211235

Substantially Equivalent

Ortho8, Inc.

FDA 510(k) clearance K211235 for CIRCUL8 Luxe DVT Prevention Device, Substantially Equivalent on 2021-09-08. Applicant: Ortho8, Inc..

Clearance details

Applicant: Ortho8, Inc.
Product code: Code JOW
Advisory panel: Cardiovascular
Date received: 2021-04-26
Decision date: 2021-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rocklin, CA, US

Download summary PDF View on FDA.gov ↗

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