ExoAtlet-II— 510(k) K201473

Substantially Equivalent

Exoatlet Asia Co. , Ltd.

FDA 510(k) clearance K201473 for ExoAtlet-II, Substantially Equivalent on 2021-07-16. Applicant: Exoatlet Asia Co. , Ltd.. Device class: 2.

Clearance details

Applicant: Exoatlet Asia Co. , Ltd.
Product code: Code PHL
Device class: Class 2
Regulation: 21 CFR 890.3480
Advisory panel: Physical Medicine
Date received: 2020-06-03
Decision date: 2021-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denver, CO, 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.